<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01728584</url>
  </required_header>
  <id_info>
    <org_study_id>P07982</org_study_id>
    <secondary_id>MK-8616-076</secondary_id>
    <secondary_id>2012-001886-33</secondary_id>
    <nct_id>NCT01728584</nct_id>
  </id_info>
  <brief_title>A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)</brief_title>
  <official_title>Randomized, Controlled, Parallel-Group, Double-Blind Trial to Compare the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures Using a 2x2 Factorial Design in Patients Undergoing Laparoscopic Cholecystectomy (Protocol No. MK-8616-076-03 Also Known as SCH 900616, P07982)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to compare the use of deep or standard neuromuscular&#xD;
      blockade (NMB) in combination with low or standard insufflation pressure in participants&#xD;
      undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the&#xD;
      injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow&#xD;
      visualization of and access to the surgical field. The primary hypothesis of the study is&#xD;
      that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical&#xD;
      conditions as compared to standard NMB. The in-patient surgery is performed on Day 1 and the&#xD;
      participant remains hospitalized for at least 48 hours following the surgery (or at least 24&#xD;
      hours following the surgery, if local practice does not allow 48 hours of hospitalization&#xD;
      post surgery). On Day 8, a follow-up visit/contact including all participants occurs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During procedure, surgeon (who was blinded to random assignment) could request that unblinded&#xD;
      anesthetist change the randomized treatment conditions (called a &quot;rescue intervention&quot;), if&#xD;
      surgeon considered surgical conditions to be unacceptable. This was to be done systematically&#xD;
      as follows: If the participant is on standard NMB, the preferred rescue intervention should&#xD;
      be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if&#xD;
      participant is also on low insufflation pressure) should be the increase of insufflation&#xD;
      pressure by 4 mmHg. If the participant is already on deep NMB, the preferred option should be&#xD;
      (if participant is also on low insufflation pressure) the increase of insufflation pressure&#xD;
      by 4 mmHg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2012</start_date>
  <completion_date type="Actual">April 29, 2014</completion_date>
  <primary_completion_date type="Actual">April 29, 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)</measure>
    <time_frame>End of surgery (Day 1)</time_frame>
    <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): &quot;How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm</measure>
    <time_frame>End of surgery (Day 1)</time_frame>
    <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): &quot;How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)</measure>
    <time_frame>Up to 24 hours after administration of sugammadex on Day 1</time_frame>
    <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm</measure>
    <time_frame>Up to 24 hours after administration of sugammadex on Day 1</time_frame>
    <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)</measure>
    <time_frame>End of surgery (Day 1)</time_frame>
    <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): &quot;How satisfied were you overall with the visual field during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)</measure>
    <time_frame>End of surgery (Day 1)</time_frame>
    <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): &quot;How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)</measure>
    <time_frame>End of surgery (Day 1)</time_frame>
    <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): &quot;How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)</measure>
    <time_frame>During surgery, approximate duration of 1-2 hours (Day 1)</time_frame>
    <description>At the end of the procedure the surgeon responds to the following question: &quot;How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)</measure>
    <time_frame>End of surgery (Day 1)</time_frame>
    <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): &quot;How did the patient movements described above disrupt your surgical performance?&quot; This refers to participant movements during surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm</measure>
    <time_frame>During surgery, approximate duration of 1-2 hours (Day 1)</time_frame>
    <description>During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a &quot;rescue intervention&quot;), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm</measure>
    <time_frame>Days 2 to 8</time_frame>
    <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm</measure>
    <time_frame>Days 2 to 8</time_frame>
    <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm</measure>
    <time_frame>Days 2 to 8</time_frame>
    <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Post operative use of pain/analgesic medication by participant through Day 8 was recorded.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Gallbladder Disease</condition>
  <arm_group>
    <arm_group_label>Standard NMB and Standard Insufflation Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment condition for this arm is Standard NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment condition for this arm is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep NMB and Standard Insufflation Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. - Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). - Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).</description>
    <arm_group_label>Deep NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_label>Deep NMB and Standard Insufflation Pressure</arm_group_label>
    <arm_group_label>Standard NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_label>Standard NMB and Standard Insufflation Pressure</arm_group_label>
    <other_name>Zemuron® Injection (rocuronium bromide)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Insufflation</intervention_name>
    <description>Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.&#xD;
Standard insufflation pressure - a starting pressure of 12 mmHg will be used.&#xD;
Low insufflation pressure - a starting pressure of 8 mmHg will be used.</description>
    <arm_group_label>Deep NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_label>Deep NMB and Standard Insufflation Pressure</arm_group_label>
    <arm_group_label>Standard NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_label>Standard NMB and Standard Insufflation Pressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <description>NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.</description>
    <arm_group_label>Deep NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_label>Deep NMB and Standard Insufflation Pressure</arm_group_label>
    <arm_group_label>Standard NMB and Low Insufflation Pressure</arm_group_label>
    <arm_group_label>Standard NMB and Standard Insufflation Pressure</arm_group_label>
    <other_name>sugammadex sodium injection</other_name>
    <other_name>SCH 900616</other_name>
    <other_name>Org 25969</other_name>
    <other_name>Bridion®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Class 1 or 2 or 3&#xD;
&#xD;
          -  Scheduled to undergo an elective in-patient laparoscopic cholecystectomy procedure&#xD;
             under general anesthesia with total intravenous anesthesia (TIVA) using propofol and&#xD;
             remifentanil&#xD;
&#xD;
          -  Eligible to undergo rocuronium-induced NMB for endotracheal intubation and maintenance&#xD;
             of NMB&#xD;
&#xD;
          -  Will recover in the post-anesthesia care unit (PACU) and remain in the hospital for at&#xD;
             least 48 hours following the surgical procedure (or at least 24 hours following the&#xD;
             surgical procedure, if local practice does not allow 48 hours of hospitalization post&#xD;
             surgery)&#xD;
&#xD;
          -  Body mass index (BMI) ≤35&#xD;
&#xD;
          -  Willing and able to adhere to visit schedules including all required study assessments&#xD;
             on Day 3 through 8 (daily pain and medication diary entry)&#xD;
&#xD;
          -  For sexually active female participants of child-bearing potential - able to use a&#xD;
             medically accepted method of contraception through 7 days after receiving&#xD;
             protocol-specified medication&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Neuromuscular disorders that may affect NMB and/or trial assessments&#xD;
&#xD;
          -  Lifetime history of previous abdominal surgery, including laparotomies, Cesarean&#xD;
             section, laparoscopic procedures or diagnostic laparoscopies&#xD;
&#xD;
          -  Substance abuse or dependence (excluding nicotine) within the past 6 months&#xD;
&#xD;
          -  History of a chronic pain condition (requiring continuous/daily pain medication prior&#xD;
             to surgery)&#xD;
&#xD;
          -  For female participants - lifetime history of a Cesarean section, or has given birth&#xD;
             to one or more children within the last year, or is currently pregnant or has the&#xD;
             intention to become pregnant between randomization and pregnancy follow-up contact ≥30&#xD;
             days after administration of trial treatments (rocuronium, sugammadex)&#xD;
&#xD;
          -  Evidence of acute cholecystitis&#xD;
&#xD;
          -  Dialysis-dependency or suspected of having severe renal insufficiency&#xD;
&#xD;
          -  Significant hepatic dysfunction that would prevent participation in the trial&#xD;
&#xD;
          -  History of or family history of malignant hyperthermia&#xD;
&#xD;
          -  Allergy to trial treatments (rocuronium or sugammadex) or their excipients, to&#xD;
             opioids/opiates, or other medication used during general anesthesia&#xD;
&#xD;
          -  Received or is planned to receive toremifene or fusidic acid within 24 hours before or&#xD;
             after receiving rocuronium or sugammadex&#xD;
&#xD;
          -  Expected transfer to an Intensive Care Unit after surgery&#xD;
&#xD;
          -  Any clinically significant condition or situation, other than the reason for the&#xD;
             cholecystectomy that would interfere with the trial evaluations or optimal&#xD;
             participation in the trial&#xD;
&#xD;
          -  Used any investigational drugs within 30 days of randomization&#xD;
&#xD;
          -  Participated in any other clinical trial within 30 days of signing the informed&#xD;
             consent form of the current trial&#xD;
&#xD;
          -  Participated in any other clinical trial involving any personnel of the&#xD;
             investigational or Sponsor staff directly involved with this trial&#xD;
&#xD;
          -  Is a family member of any personnel of the investigational or Sponsor staff directly&#xD;
             involved with this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Merck Sharp &amp; Dohme GmbH</name>
      <address>
        <city>Haar</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MSD Italia S.r.l.</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
    <country>Finland</country>
    <country>United Kingdom</country>
  </removed_countries>
  <results_reference>
    <citation>Rosenberg J, Herring WJ, Blobner M, Mulier JP, Rahe-Meyer N, Woo T, Li MK, Grobara P, Assaid CA, Fennema H, Szegedi A. Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study. Adv Ther. 2017 Apr;34(4):925-936. doi: 10.1007/s12325-017-0495-x. Epub 2017 Mar 1.</citation>
    <PMID>28251555</PMID>
  </results_reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>March 12, 2015</results_first_submitted>
  <results_first_submitted_qc>March 12, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 23, 2015</results_first_posted>
  <last_update_submitted>September 17, 2018</last_update_submitted>
  <last_update_submitted_qc>September 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallbladder Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were randomized to 4 arms based on combinations of neuromuscular blockade (NMB) depth and insufflation pressure level. During procedure, blinded surgeon could request that unblinded anesthetist change the randomized treatment conditions (&quot;rescue intervention&quot;), if surgeon considered surgical conditions to be unacceptable.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard NMB and Standard Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
        </group>
        <group group_id="P2">
          <title>Standard NMB and Low Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
        </group>
        <group group_id="P3">
          <title>Deep NMB and Standard Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts [PTCs])/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
        </group>
        <group group_id="P4">
          <title>Deep NMB and Low Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36">Randomized</participants>
                <participants group_id="P2" count="30">Randomized - NMB/pressure conditions were changed in 7 (2 to Std/Std, 4 to Deep/Std, 1 to Deep/Low)</participants>
                <participants group_id="P3" count="31">Randomized</participants>
                <participants group_id="P4" count="30">Randomized - NMB/pressure conditions were changed in 5 (all to Deep/Std)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason (not specified)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants as randomized</population>
      <group_list>
        <group group_id="B1">
          <title>Standard NMB and Standard Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
        </group>
        <group group_id="B2">
          <title>Standard NMB and Low Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
        </group>
        <group group_id="B3">
          <title>Deep NMB and Standard Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
        </group>
        <group group_id="B4">
          <title>Deep NMB and Low Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="30"/>
            <count group_id="B5" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.1" spread="17.7"/>
                    <measurement group_id="B2" value="39.1" spread="13.6"/>
                    <measurement group_id="B3" value="43.5" spread="15.6"/>
                    <measurement group_id="B4" value="46.7" spread="13.8"/>
                    <measurement group_id="B5" value="43.9" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)</title>
        <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): &quot;How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
        <time_frame>End of surgery (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O2">
            <title>Deep NMB</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O3">
            <title>Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.</description>
          </group>
          <group group_id="O4">
            <title>Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
        </group_list>
        <measure>
          <title>Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)</title>
          <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): &quot;How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.83" lower_limit="5.97" upper_limit="7.69"/>
                    <measurement group_id="O2" value="7.92" lower_limit="7.05" upper_limit="8.80"/>
                    <measurement group_id="O3" value="8.89" lower_limit="8.05" upper_limit="9.72"/>
                    <measurement group_id="O4" value="5.87" lower_limit="4.96" upper_limit="6.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Primary hypothesis - deep NMB improves surgeon's overall satisfaction with the surgical conditions compared to standard NMB</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis of covariance (ANCOVA) model included factors depth of NMB, level of pressure, surgeon and body mass index (BMI)</method_desc>
            <param_type>Difference in Least Squares (LS) Means</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>2.04</ci_upper_limit>
            <estimate_desc>Difference is deep versus standard NMB</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>-3.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.99</ci_lower_limit>
            <ci_upper_limit>-2.05</ci_upper_limit>
            <estimate_desc>Difference is low versus standard pressure</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm</title>
        <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): &quot;How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
        <time_frame>End of surgery (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O2">
            <title>Standard NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
          <group group_id="O3">
            <title>Deep NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O4">
            <title>Deep NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
        </group_list>
        <measure>
          <title>Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm</title>
          <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): &quot;How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>score on a acale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.65" lower_limit="7.58" upper_limit="9.72"/>
                    <measurement group_id="O2" value="4.99" lower_limit="3.88" upper_limit="6.11"/>
                    <measurement group_id="O3" value="9.09" lower_limit="8.82" upper_limit="10.17"/>
                    <measurement group_id="O4" value="6.69" lower_limit="5.57" upper_limit="7.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Least Squares (LS) Means</param_type>
            <param_value>3.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.30</ci_lower_limit>
            <ci_upper_limit>5.02</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/standard pressure versus standard NMB/low pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.80</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/standard pressure versus deep NMB/standard pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>1.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>3.36</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/standard pressure versus deep NMB/low pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-4.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.42</ci_lower_limit>
            <ci_upper_limit>-2.78</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/low pressure versus deep NMB/standard pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-1.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.01</ci_lower_limit>
            <ci_upper_limit>-0.38</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/low pressure versus deep NMB/low pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>2.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.08</ci_lower_limit>
            <ci_upper_limit>3.74</ci_upper_limit>
            <estimate_desc>Difference is deep NMB/standard pressure versus deep NMB/low pressure</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)</title>
        <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.</description>
        <time_frame>Up to 24 hours after administration of sugammadex on Day 1</time_frame>
        <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O2">
            <title>Deep NMB</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O3">
            <title>Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.</description>
          </group>
          <group group_id="O4">
            <title>Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)</title>
          <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.</description>
          <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="71"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.48" lower_limit="2.02" upper_limit="2.93"/>
                    <measurement group_id="O2" value="2.83" lower_limit="2.39" upper_limit="3.28"/>
                    <measurement group_id="O3" value="2.74" lower_limit="2.34" upper_limit="3.15"/>
                    <measurement group_id="O4" value="2.57" lower_limit="2.07" upper_limit="3.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.148</p_value>
            <method>ANOVA</method>
            <method_desc>Analysis of variance (ANOVA) model included factors depth of NMB, level of pressure, gender and surgeon</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>0.84</ci_upper_limit>
            <estimate_desc>Difference is deep versus standard NMB</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Key secondary hypothesis - low insufflation pressure improves overall average pain score in first 24 hours compared to standard insufflation pressure</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.494</p_value>
            <p_value_desc>To control for multiple testing, this difference was formally tested only if comparison of surgeon's overall satisfaction with surgical conditions for deep versus standard NMB was significant at the 5% level, with greater satisfaction for deep NMB.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>ANOVA model included factors depth of NMB, level of pressure, gender and surgeon</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.67</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
            <estimate_desc>Difference is low versus standard pressure</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm</title>
        <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.</description>
        <time_frame>Up to 24 hours after administration of sugammadex on Day 1</time_frame>
        <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O2">
            <title>Standard NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
          <group group_id="O3">
            <title>Deep NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O4">
            <title>Deep NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm</title>
          <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.</description>
          <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" lower_limit="1.90" upper_limit="2.93"/>
                    <measurement group_id="O2" value="2.62" lower_limit="1.98" upper_limit="3.26"/>
                    <measurement group_id="O3" value="3.06" lower_limit="2.56" upper_limit="3.57"/>
                    <measurement group_id="O4" value="2.57" lower_limit="1.97" upper_limit="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>ANOVA model included factors treatment group, gender and surgeon</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.92</ci_lower_limit>
            <ci_upper_limit>0.52</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/standard pressure versus standard NMB/low pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANOVA model included factors treatment group, gender and surgeon</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/standard pressure versus deep NMB/standard pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>ANOVA model included factors treatment group, gender and surgeon</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.84</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/standard pressure versus deep NMB/low pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ANOVA model included factors treatment group, gender and surgeon</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.15</ci_lower_limit>
            <ci_upper_limit>0.26</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/low pressure versus deep NMB/standard pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>ANOVA model included factors treatment group, gender and surgeon</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.69</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
            <estimate_desc>Difference is standard NMB/low pressure versus deep NMB/low pressure</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>ANOVA model included factors treatment group, gender and surgeon</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
            <estimate_desc>Difference is deep NMB/standard pressure versus deep NMB/low pressure</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)</title>
        <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): &quot;How satisfied were you overall with the visual field during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
        <time_frame>End of surgery (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O2">
            <title>Deep NMB</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
        </group_list>
        <measure>
          <title>Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)</title>
          <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): &quot;How satisfied were you overall with the visual field during the surgery you just performed?&quot; If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.88" lower_limit="6.02" upper_limit="7.75"/>
                    <measurement group_id="O2" value="7.80" lower_limit="6.92" upper_limit="8.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.063</p_value>
            <p_value_desc>Not controlled for multiple testing</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>1.87</ci_upper_limit>
            <estimate_desc>Difference is deep versus standard NMB</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)</title>
        <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): &quot;How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?&quot;</description>
        <time_frame>End of surgery (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O2">
            <title>Deep NMB</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
        </group_list>
        <measure>
          <title>Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)</title>
          <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): &quot;How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?&quot;</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.05" lower_limit="7.56" upper_limit="8.54"/>
                    <measurement group_id="O2" value="8.87" lower_limit="8.37" upper_limit="9.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>Not controlled for multiple testing</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
            <estimate_desc>Difference is deep versus standard NMB</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)</title>
        <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): &quot;How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?&quot;</description>
        <time_frame>End of surgery (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O2">
            <title>Deep NMB</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
        </group_list>
        <measure>
          <title>Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)</title>
          <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): &quot;How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?&quot;</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" lower_limit="6.01" upper_limit="7.45"/>
                    <measurement group_id="O2" value="7.86" lower_limit="7.12" upper_limit="8.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>Not controlled for multiple testing</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.92</ci_upper_limit>
            <estimate_desc>Difference is deep versus standard NMB</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)</title>
        <description>At the end of the procedure the surgeon responds to the following question: &quot;How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?&quot;</description>
        <time_frame>During surgery, approximate duration of 1-2 hours (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O2">
            <title>Deep NMB</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)</title>
          <description>At the end of the procedure the surgeon responds to the following question: &quot;How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?&quot;</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>instances of occurrence that interfered</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" lower_limit="0.33" upper_limit="1.52"/>
                    <measurement group_id="O2" value="0.32" lower_limit="-0.29" upper_limit="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.073</p_value>
            <p_value_desc>Not controlled for multiple testing</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
            <estimate_desc>Difference is deep versus standard NMB</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)</title>
        <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): &quot;How did the patient movements described above disrupt your surgical performance?&quot; This refers to participant movements during surgery.</description>
        <time_frame>End of surgery (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.</description>
          </group>
          <group group_id="O2">
            <title>Deep NMB</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.</description>
          </group>
        </group_list>
        <measure>
          <title>Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)</title>
          <description>At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): &quot;How did the patient movements described above disrupt your surgical performance?&quot; This refers to participant movements during surgery.</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.21" lower_limit="8.72" upper_limit="9.70"/>
                    <measurement group_id="O2" value="9.94" lower_limit="9.45" upper_limit="10.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.009</p_value>
            <p_value_desc>Not controlled for multiple testing</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.19</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
            <estimate_desc>Difference is deep versus standard NMB</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm</title>
        <description>During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a &quot;rescue intervention&quot;), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.</description>
        <time_frame>During surgery, approximate duration of 1-2 hours (Day 1)</time_frame>
        <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O2">
            <title>Standard NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
          <group group_id="O3">
            <title>Deep NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O4">
            <title>Deep NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm</title>
          <description>During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a &quot;rescue intervention&quot;), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.</description>
          <population>Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number with rescue action performed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number with rescue change in depth of NMB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number with rescue change in pressure level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm</title>
        <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.</description>
        <time_frame>Days 2 to 8</time_frame>
        <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O2">
            <title>Standard NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
          <group group_id="O3">
            <title>Deep NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O4">
            <title>Deep NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm</title>
          <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.</description>
          <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours after sugammadex dose (n=29, 22, 38, 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.66" spread="1.45"/>
                    <measurement group_id="O2" value="2.23" spread="2.09"/>
                    <measurement group_id="O3" value="2.24" spread="1.62"/>
                    <measurement group_id="O4" value="2.48" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours after sugammadex dose (n=27, 22, 33, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="1.45"/>
                    <measurement group_id="O2" value="1.41" spread="1.68"/>
                    <measurement group_id="O3" value="1.73" spread="1.53"/>
                    <measurement group_id="O4" value="1.83" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 (N=22, 20, 30, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86" spread="0.89"/>
                    <measurement group_id="O2" value="1.65" spread="1.76"/>
                    <measurement group_id="O3" value="1.87" spread="1.59"/>
                    <measurement group_id="O4" value="2.00" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 (N=28, 20, 37, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="1.23"/>
                    <measurement group_id="O2" value="1.05" spread="1.50"/>
                    <measurement group_id="O3" value="1.76" spread="1.55"/>
                    <measurement group_id="O4" value="1.04" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 (N=27, 21, 38, 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="1.01"/>
                    <measurement group_id="O2" value="1.00" spread="1.48"/>
                    <measurement group_id="O3" value="1.45" spread="1.35"/>
                    <measurement group_id="O4" value="0.92" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 (N=27, 20, 35, 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.75"/>
                    <measurement group_id="O2" value="0.85" spread="1.39"/>
                    <measurement group_id="O3" value="1.31" spread="1.55"/>
                    <measurement group_id="O4" value="0.75" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 (N=27, 21, 34, 22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" spread="0.64"/>
                    <measurement group_id="O2" value="0.95" spread="1.43"/>
                    <measurement group_id="O3" value="1.18" spread="1.57"/>
                    <measurement group_id="O4" value="0.59" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 (N=28, 21, 35, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.79"/>
                    <measurement group_id="O2" value="0.81" spread="1.29"/>
                    <measurement group_id="O3" value="0.94" spread="1.24"/>
                    <measurement group_id="O4" value="0.43" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm</title>
        <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.</description>
        <time_frame>Days 2 to 8</time_frame>
        <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O2">
            <title>Standard NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
          <group group_id="O3">
            <title>Deep NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O4">
            <title>Deep NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm</title>
          <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.</description>
          <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours after sugammadex dose (n=29, 22, 38, 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.38" spread="2.37"/>
                    <measurement group_id="O2" value="3.27" spread="2.76"/>
                    <measurement group_id="O3" value="3.68" spread="1.92"/>
                    <measurement group_id="O4" value="3.76" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours after sugammadex dose (n=27, 22, 33, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="1.96"/>
                    <measurement group_id="O2" value="2.14" spread="2.19"/>
                    <measurement group_id="O3" value="2.94" spread="2.08"/>
                    <measurement group_id="O4" value="2.91" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 (N=22, 20, 30, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="1.51"/>
                    <measurement group_id="O2" value="2.50" spread="2.33"/>
                    <measurement group_id="O3" value="2.97" spread="2.11"/>
                    <measurement group_id="O4" value="3.24" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 (N=28, 20, 37, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="1.69"/>
                    <measurement group_id="O2" value="1.85" spread="1.95"/>
                    <measurement group_id="O3" value="3.05" spread="2.17"/>
                    <measurement group_id="O4" value="1.91" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 (N=27, 21, 38, 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="1.54"/>
                    <measurement group_id="O2" value="1.90" spread="1.84"/>
                    <measurement group_id="O3" value="2.58" spread="1.90"/>
                    <measurement group_id="O4" value="1.71" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 (N=27, 20, 35, 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="1.59"/>
                    <measurement group_id="O2" value="1.40" spread="1.82"/>
                    <measurement group_id="O3" value="2.51" spread="2.06"/>
                    <measurement group_id="O4" value="1.42" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 (N=27, 21, 34, 22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="1.28"/>
                    <measurement group_id="O2" value="1.52" spread="1.66"/>
                    <measurement group_id="O3" value="2.21" spread="2.24"/>
                    <measurement group_id="O4" value="1.23" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 (N=28, 21, 35, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="1.34"/>
                    <measurement group_id="O2" value="1.38" spread="1.75"/>
                    <measurement group_id="O3" value="1.91" spread="2.02"/>
                    <measurement group_id="O4" value="0.81" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm</title>
        <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.</description>
        <time_frame>Days 2 to 8</time_frame>
        <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O2">
            <title>Standard NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
          <group group_id="O3">
            <title>Deep NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O4">
            <title>Deep NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
        </group_list>
        <measure>
          <title>Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm</title>
          <description>Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.</description>
          <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 hours after sugammadex dose (n=29, 22, 38, 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="1.71"/>
                    <measurement group_id="O2" value="1.18" spread="2.15"/>
                    <measurement group_id="O3" value="1.05" spread="1.66"/>
                    <measurement group_id="O4" value="1.40" spread="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours after sugammadex dose (n=27, 22, 33, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.97"/>
                    <measurement group_id="O2" value="0.64" spread="1.22"/>
                    <measurement group_id="O3" value="0.76" spread="1.23"/>
                    <measurement group_id="O4" value="0.96" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 (N=22, 20, 30, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.50"/>
                    <measurement group_id="O2" value="0.80" spread="1.32"/>
                    <measurement group_id="O3" value="0.67" spread="1.40"/>
                    <measurement group_id="O4" value="0.88" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 (N=28, 20, 37, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="1.09"/>
                    <measurement group_id="O2" value="0.55" spread="1.23"/>
                    <measurement group_id="O3" value="0.70" spread="1.60"/>
                    <measurement group_id="O4" value="0.61" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 (N=27, 21, 38, 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.43" spread="0.81"/>
                    <measurement group_id="O3" value="0.68" spread="1.65"/>
                    <measurement group_id="O4" value="0.25" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 (N=27, 20, 35, 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.15" spread="0.37"/>
                    <measurement group_id="O3" value="0.63" spread="1.55"/>
                    <measurement group_id="O4" value="0.21" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 (N=27, 21, 34, 22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.14" spread="0.48"/>
                    <measurement group_id="O3" value="0.68" spread="1.63"/>
                    <measurement group_id="O4" value="0.23" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 (N=28, 21, 35, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.19"/>
                    <measurement group_id="O2" value="0.24" spread="0.44"/>
                    <measurement group_id="O3" value="0.66" spread="1.49"/>
                    <measurement group_id="O4" value="0.14" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm</title>
        <description>Post operative use of pain/analgesic medication by participant through Day 8 was recorded.</description>
        <time_frame>Up to Day 8</time_frame>
        <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O2">
            <title>Standard NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
          <group group_id="O3">
            <title>Deep NMB and Standard Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
          </group>
          <group group_id="O4">
            <title>Deep NMB and Low Insufflation Pressure</title>
            <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm</title>
          <description>Post operative use of pain/analgesic medication by participant through Day 8 was recorded.</description>
          <population>Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</population>
          <units>participants using pain medication</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="40"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Within 3 hours post surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 to 24 hours post surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 to 48 hours post surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 48 hours and end of Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On Day 6, 7 or 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 8</time_frame>
      <desc>Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard NMB and Standard Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
        </group>
        <group group_id="E2">
          <title>Standard NMB and Low Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
        </group>
        <group group_id="E3">
          <title>Deep NMB and Standard Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).</description>
        </group>
        <group group_id="E4">
          <title>Deep NMB and Low Insufflation Pressure</title>
          <description>Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Wound haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="39" subjects_at_risk="40"/>
                <counts group_id="E4" subjects_affected="26" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="33"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="46" subjects_affected="28" subjects_at_risk="33"/>
                <counts group_id="E2" events="34" subjects_affected="19" subjects_at_risk="23"/>
                <counts group_id="E3" events="63" subjects_affected="34" subjects_at_risk="40"/>
                <counts group_id="E4" events="42" subjects_affected="24" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Wound haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Initial public presentation of the Investigator's results will occur only together with the other sites unless permission is obtained from Sponsor. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. In case of disagreement concerning appropriateness of materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues, prior to submission for publication/presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728584
org study id: P07982
secondary id: MK-8616-076
secondary id: 2012-001886-33
nct id: NCT01728584
lead sponsor: 
has dmc: No
The purpose of this pilot study is to compare the use of deep or standard neuromuscular
      blockade (NMB) in combination with low or standard insufflation pressure in participants
      undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the
      injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow
      visualization of and access to the surgical field. The primary hypothesis of the study is
      that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical
      conditions as compared to standard NMB. The in-patient surgery is performed on Day 1 and the
      participant remains hospitalized for at least 48 hours following the surgery (or at least 24
      hours following the surgery, if local practice does not allow 48 hours of hospitalization
      post surgery). On Day 8, a follow-up visit/contact including all participants occurs.
During procedure, surgeon (who was blinded to random assignment) could request that unblinded
      anesthetist change the randomized treatment conditions (called a "rescue intervention"), if
      surgeon considered surgical conditions to be unacceptable. This was to be done systematically
      as follows: If the participant is on standard NMB, the preferred rescue intervention should
      be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if
      participant is also on low insufflation pressure) should be the increase of insufflation
      pressure by 4 mmHg. If the participant is already on deep NMB, the preferred option should be
      (if participant is also on low insufflation pressure) the increase of insufflation pressure
      by 4 mmHg.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)
time frame: End of surgery (Day 1)
description: At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): "How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?" If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
measure: Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm
time frame: End of surgery (Day 1)
description: At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): "How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?" If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
measure: Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)
time frame: Up to 24 hours after administration of sugammadex on Day 1
description: Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.
measure: Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm
time frame: Up to 24 hours after administration of sugammadex on Day 1
description: Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.
measure: Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)
time frame: End of surgery (Day 1)
description: At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): "How satisfied were you overall with the visual field during the surgery you just performed?" If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
measure: Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)
time frame: End of surgery (Day 1)
description: At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): "How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"
measure: Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)
time frame: End of surgery (Day 1)
description: At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): "How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"
measure: Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)
time frame: During surgery, approximate duration of 1-2 hours (Day 1)
description: At the end of the procedure the surgeon responds to the following question: "How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?"
measure: Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)
time frame: End of surgery (Day 1)
description: At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): "How did the patient movements described above disrupt your surgical performance?" This refers to participant movements during surgery.
measure: Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm
time frame: During surgery, approximate duration of 1-2 hours (Day 1)
description: During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a "rescue intervention"), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.
measure: Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm
time frame: Days 2 to 8
description: Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.
measure: Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm
time frame: Days 2 to 8
description: Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.
measure: Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm
time frame: Days 2 to 8
description: Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.
measure: Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm
time frame: Up to Day 8
description: Post operative use of pain/analgesic medication by participant through Day 8 was recorded.
arm group label: Standard NMB and Standard Insufflation Pressure
arm group type: Experimental
description: Treatment condition for this arm is Standard NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
arm group label: Standard NMB and Low Insufflation Pressure
arm group type: Experimental
description: Treatment condition for this arm is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
arm group label: Deep NMB and Standard Insufflation Pressure
arm group type: Experimental
description: Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
arm group label: Deep NMB and Low Insufflation Pressure
arm group type: Experimental
description: Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
intervention type: Drug
intervention name: Rocuronium
description: NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. - Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). - Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
arm group label: Deep NMB and Low Insufflation Pressure
arm group label: Deep NMB and Standard Insufflation Pressure
arm group label: Standard NMB and Low Insufflation Pressure
arm group label: Standard NMB and Standard Insufflation Pressure
other name: Zemuron® Injection (rocuronium bromide)
intervention type: Other
intervention name: Insufflation
description: Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
Standard insufflation pressure - a starting pressure of 12 mmHg will be used.
Low insufflation pressure - a starting pressure of 8 mmHg will be used.
arm group label: Deep NMB and Low Insufflation Pressure
arm group label: Deep NMB and Standard Insufflation Pressure
arm group label: Standard NMB and Low Insufflation Pressure
arm group label: Standard NMB and Standard Insufflation Pressure
intervention type: Drug
intervention name: Sugammadex
description: NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
arm group label: Deep NMB and Low Insufflation Pressure
arm group label: Deep NMB and Standard Insufflation Pressure
arm group label: Standard NMB and Low Insufflation Pressure
arm group label: Standard NMB and Standard Insufflation Pressure
other name: sugammadex sodium injection
other name: SCH 900616
other name: Org 25969
other name: Bridion®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
facility: 
country: Germany
country: Italy
country: Austria
country: Finland
country: United Kingdom
citation: Rosenberg J, Herring WJ, Blobner M, Mulier JP, Rahe-Meyer N, Woo T, Li MK, Grobara P, Assaid CA, Fennema H, Szegedi A. Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study. Adv Ther. 2017 Apr;34(4):925-936. doi: 10.1007/s12325-017-0495-x. Epub 2017 Mar 1.
PMID: 28251555
responsible party type: Sponsor
mesh term: Gallbladder Diseases
mesh term: Bromides
mesh term: Rocuronium
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 