<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/NCT02185339</url>
  </required_header>
  <id_info>
    <org_study_id>dNMBonResp</org_study_id>
    <nct_id>NCT02185339</nct_id>
  </id_info>
  <brief_title>Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics</brief_title>
  <official_title>Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul St. Mary's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the current study is to compare intraoperative respiratory mechanics&#xD;
      in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and&#xD;
      under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative&#xD;
      hemodynamics and postoperative pulmonary function between the two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thoracopulmonary Compliance</measure>
    <time_frame>intraoperative</time_frame>
    <description>Was measured with a patient spirometry monitor through a flow sensor.&#xD;
Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial Oxygen Tension/Inspired Oxygen Fraction</measure>
    <time_frame>intraoperative</time_frame>
    <description>Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference</measure>
    <time_frame>intraoperative</time_frame>
    <description>Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Dead Space</measure>
    <time_frame>intraoperative</time_frame>
    <description>Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Shunt</measure>
    <time_frame>intraoperative</time_frame>
    <description>Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stroke Volume Variation</measure>
    <time_frame>intraoperative</time_frame>
    <description>Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Index</measure>
    <time_frame>intraoperative</time_frame>
    <description>Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
  </other_outcome>
  <other_outcome>
    <measure>Surgical Condition</measure>
    <time_frame>At completion of pneumoperitoneum surgery</time_frame>
    <description>Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>Postoperative 2 days</time_frame>
    <description>Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 10).&#xD;
Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Laparoscopic Renal Surgery</condition>
  <condition>Laparoscopy</condition>
  <condition>Muscle Relaxation</condition>
  <arm_group>
    <arm_group_label>dNMB group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mNMB group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count &gt;2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.</description>
    <arm_group_label>dNMB group</arm_group_label>
    <other_name>Esmeron®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.</description>
    <arm_group_label>mNMB group</arm_group_label>
    <other_name>Esmeron®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I or II patients scheduled to undergo laparoscopic renal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI ≥35 kg/m2&#xD;
&#xD;
          -  Known neuromuscular disease&#xD;
&#xD;
          -  History of chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Pneumothorax&#xD;
&#xD;
          -  Bronchopleural fistula&#xD;
&#xD;
          -  Previous lung surgery&#xD;
&#xD;
          -  Previous retroperitoneal surgery&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  History of cardiopulmonary disease&#xD;
&#xD;
          -  Renal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang-Hyun Hong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>March 30, 2016</results_first_submitted>
  <results_first_submitted_qc>May 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 24, 2016</results_first_posted>
  <last_update_submitted>June 23, 2016</last_update_submitted>
  <last_update_submitted_qc>June 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Sanghyun Hong</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Respiratory mechanics</keyword>
  <keyword>Respiratory function test</keyword>
  <keyword>Hemodynamics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened and enrolled at Seoul St. Mary's Hospital from July 2014 to January 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
          <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
        </group>
        <group group_id="P2">
          <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
          <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
          <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
        </group>
        <group group_id="B2">
          <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
          <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
        </group>
        <group group_id="B3">
          <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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </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="48.3" spread="10.7"/>
                    <measurement group_id="B2" value="49.8" spread="11.0"/>
                    <measurement group_id="B3" value="49.1" spread="10.8"/>
                  </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="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Thoracopulmonary Compliance</title>
        <description>Was measured with a patient spirometry monitor through a flow sensor.&#xD;
Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Thoracopulmonary Compliance</title>
          <description>Was measured with a patient spirometry monitor through a flow sensor.&#xD;
Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).</description>
          <units>ml/cmH2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T Lateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.9" spread="9.8"/>
                    <measurement group_id="O2" value="52.3" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" spread="6.8"/>
                    <measurement group_id="O2" value="31.9" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.6" spread="7.7"/>
                    <measurement group_id="O2" value="30.8" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T EndPP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.1" spread="11.5"/>
                    <measurement group_id="O2" value="52.6" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Arterial Oxygen Tension/Inspired Oxygen Fraction</title>
        <description>Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Arterial Oxygen Tension/Inspired Oxygen Fraction</title>
          <description>Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T Lateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="477" spread="100"/>
                    <measurement group_id="O2" value="483" spread="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="467" spread="103"/>
                    <measurement group_id="O2" value="461" spread="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="468" spread="86"/>
                    <measurement group_id="O2" value="465" spread="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T EndPP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493" spread="82"/>
                    <measurement group_id="O2" value="487" spread="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference</title>
        <description>Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference</title>
          <description>Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T Lateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="1.7"/>
                    <measurement group_id="O2" value="4.3" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="2.1"/>
                    <measurement group_id="O2" value="7.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="2.6"/>
                    <measurement group_id="O2" value="7.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T EndPP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.1"/>
                    <measurement group_id="O2" value="5.3" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Dead Space</title>
        <description>Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Dead Space</title>
          <description>Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
          <units>% of respiratory dead space</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T Lateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="4.6"/>
                    <measurement group_id="O2" value="11.9" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="5.1"/>
                    <measurement group_id="O2" value="16.5" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="6.1"/>
                    <measurement group_id="O2" value="16.4" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T EndPP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="5.5"/>
                    <measurement group_id="O2" value="14.8" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pulmonary Shunt</title>
        <description>Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulmonary Shunt</title>
          <description>Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
          <units>% of shunt</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T Lateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" spread="5.2"/>
                    <measurement group_id="O2" value="12.4" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" spread="4.8"/>
                    <measurement group_id="O2" value="13.2" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="8.9"/>
                    <measurement group_id="O2" value="14.8" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T EndPP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="4.9"/>
                    <measurement group_id="O2" value="14.1" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stroke Volume Variation</title>
        <description>Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Stroke Volume Variation</title>
          <description>Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
          <units>% of mean stroke volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T Lateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="2.0"/>
                    <measurement group_id="O2" value="9.3" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="3.3"/>
                    <measurement group_id="O2" value="12.9" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="3.5"/>
                    <measurement group_id="O2" value="12.0" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T EndPP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="2.5"/>
                    <measurement group_id="O2" value="7.9" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cardiac Index</title>
        <description>Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Index</title>
          <description>Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.&#xD;
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.</description>
          <units>L/min/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T Lateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.4"/>
                    <measurement group_id="O2" value="2.4" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.0"/>
                    <measurement group_id="O2" value="2.6" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T Lat+PP2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="0.7"/>
                    <measurement group_id="O2" value="2.8" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T EndPP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.8"/>
                    <measurement group_id="O2" value="3.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Surgical Condition</title>
        <description>Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)</description>
        <time_frame>At completion of pneumoperitoneum surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Condition</title>
          <description>Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Extremely poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Postoperative Pain</title>
        <description>Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 10).&#xD;
Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h.</description>
        <time_frame>Postoperative 2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
            <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
            <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain</title>
          <description>Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 10).&#xD;
Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h.</description>
          <units>Scores 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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PO 1h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="2.0"/>
                    <measurement group_id="O2" value="5.9" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PO 2h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="2.1"/>
                    <measurement group_id="O2" value="4.9" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PO 6h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="2.3"/>
                    <measurement group_id="O2" value="4.5" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PO 24h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.7"/>
                    <measurement group_id="O2" value="2.4" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PO 48h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.7"/>
                    <measurement group_id="O2" value="2.4" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Deep Neuromuscular Blockade (Deep NMB) Group</title>
          <description>For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is &gt; or &lt; than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
        </group>
        <group group_id="E2">
          <title>Moderate Neuromuscular Blockade (Moderate NMB) Group</title>
          <description>For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is &gt; or &lt; than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.</description>
        </group>
      </group_list>
      <serious_events>
        <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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Sanghyun Hong</name_or_title>
      <organization>Department of Anesthesiology and Pain Medicine, The Catholic University of Korea College of Medicine, Seoul St. Mary's Hospital</organization>
      <phone>82-2-2258-2236</phone>
      <email>shhong7272@gmail.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/NCT02185339
org study id: dNMBonResp
nct id: NCT02185339
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of the current study is to compare intraoperative respiratory mechanics
      in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and
      under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative
      hemodynamics and postoperative pulmonary function between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Thoracopulmonary Compliance
time frame: intraoperative
description: Was measured with a patient spirometry monitor through a flow sensor.
Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).
measure: Arterial Oxygen Tension/Inspired Oxygen Fraction
time frame: intraoperative
description: Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
measure: Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
time frame: intraoperative
description: Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
measure: Estimated Dead Space
time frame: intraoperative
description: Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
measure: Pulmonary Shunt
time frame: intraoperative
description: Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
measure: Stroke Volume Variation
time frame: intraoperative
description: Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
measure: Cardiac Index
time frame: intraoperative
description: Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.
Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
measure: Surgical Condition
time frame: At completion of pneumoperitoneum surgery
description: Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)
measure: Postoperative Pain
time frame: Postoperative 2 days
description: Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 10).
Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h.
arm group label: dNMB group
arm group type: Experimental
description: For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.
arm group label: mNMB group
arm group type: Active Comparator
description: For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count >2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.
intervention type: Drug
intervention name: Rocuronium
description: Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.
arm group label: dNMB group
other name: Esmeron®
intervention type: Drug
intervention name: Rocuronium
description: Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.
arm group label: mNMB group
other name: Esmeron®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sang-Hyun Hong, MD
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Sanghyun Hong
investigator title: Assistant professor
mesh term: Rocuronium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 