<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/NCT03266419</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0966</org_study_id>
    <nct_id>NCT03266419</nct_id>
  </id_info>
  <brief_title>Effectiveness of Deep Versus Moderate Neuromuscular Blockade</brief_title>
  <official_title>A Double-blind, Randomized, Parallel Design to Compare the Effectiveness of Deep Versus Moderate Neuromuscular Blockade With Standard-pressure Pneumoperitoneum During Laparoscopic Gastrectomy on Postoperative Pain in Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the influence of depth of neuromuscular blockade during&#xD;
      laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to&#xD;
      either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum&#xD;
      of 13 mmHg.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  All patients were fasted from midnight without premedication&#xD;
&#xD;
        -  Once in the operating room, the patients were monitored using electrocardiography, pulse&#xD;
           oximetry, end-tidal carbon dioxide partial pressure, non-invasive blood pressure, and&#xD;
           bispectral index (Aspect 2000; Aspect Medical Systems, Inc., Newton, MA, USA)&#xD;
           measurements.&#xD;
&#xD;
        -  Neuromuscular transmission was monitored using the M-NMT® module at the adductor&#xD;
           pollicis muscle (Carescape® B850, GE Healthcare, Milwaukee, WI, USA).&#xD;
&#xD;
        -  Throughout the surgery, these data were continuously downloaded to personal computers by&#xD;
           using RS232C cables.&#xD;
&#xD;
        -  Following pre-oxygenation with 100% O2, anesthesia was induced with propofol and&#xD;
           remifentanil, which were administered using a target effect-site&#xD;
           concentration-controlled infusion pump (Perfusor® Space, B. Braun Melsungen, Germany) by&#xD;
           using the models suggested by Schnider et al. and Minto et al (Minto et al., 1997;&#xD;
           Schnider et al., 1998).&#xD;
&#xD;
        -  Tracheal intubation was facilitated with rocuronium 0.6 mg/kg.&#xD;
&#xD;
        -  After tracheal intubation, the lungs of the patients were then ventilated with oxygen in&#xD;
           air (1:1) and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide&#xD;
           partial pressure between 35 and 45 mmHg.&#xD;
&#xD;
        -  For deep NMB group, an intravenous bolus of rocuronium (0.7 mg/kg) was given 2 minutes&#xD;
           after intubation, followed by a continuous infusion of rocuronium of 0.8-1.2 mg/kg/h for&#xD;
           maintaining deep NMB (post tetanic count 1-2) during operation. PTC was measured every 5&#xD;
           minutes. In the case of deviations from the target PTC, the pump speed could be&#xD;
           increased or decreased or a bolus dose (10 mg) could be given.&#xD;
&#xD;
        -  For moderate NMB group, no further loading dose of rocuronium was given. An intravenous&#xD;
           infusion with rocuronium (0.2-0.6 mg/kg/h) was started at a TOF count of 1 for&#xD;
           maintaining moderate NMB (train of four 1-2) during operation. TOF was measured every 5&#xD;
           minutes. In the case of deviations from the target TOF, the pump speed could be&#xD;
           increased or decreased or a bolus dose (10 mg) could be given.&#xD;
&#xD;
        -  The target effect-site concentrations of propofol were adjusted within a range of 2.5-3&#xD;
           μg/ml to maintain the bispectral index values at less than 60 during the induction and&#xD;
           maintenance of anesthesia.&#xD;
&#xD;
        -  The target effect-site concentrations of remifentanil were titrated to prevent signs of&#xD;
           inadequate anesthesia and to maintain stable hemodynamics (SBP &gt; 80 mmHg and HR &gt; 45&#xD;
           beats/min).&#xD;
&#xD;
           • Signs of inadequate anesthesia: systemic arterial blood pressure increased to greater&#xD;
           than 15 mm Hg higher than the patient's normal value; heart rate exceeding 90 beats/min&#xD;
           in the absence of hypovolemia; somatic responses, such as body movements (minimal muscle&#xD;
           paralysis allowed physical movement), swallowing, coughing, grimacing, or opening of the&#xD;
           eyes; and autonomic signs of inadequate anesthesia (Ausems, Vuyk, Hug, &amp; Stanski, 1988)&#xD;
&#xD;
        -  If necessary, ephedrine or atropine is administered to maintain systolic blood pressure&#xD;
           above 80 mmHg and heart rate above 45 beats/min during anesthesia.&#xD;
&#xD;
        -  An abdominal pressure of 13 mmHg was maintained during the laparoscopic surgery.&#xD;
&#xD;
        -  When the surgeon asks for muscle relaxation due to the inability to obtain a visible&#xD;
           laparoscopic field, additional bolus dose of rocuronium (10 mg) should be given.&#xD;
&#xD;
        -  All patients were administered a bolus dose of oxycodone of 0.05 mg/kg at the end of&#xD;
           pneumoperitoneum.&#xD;
&#xD;
        -  IV PCA with oxycodone is started after the administration of loading dose. A&#xD;
           semi-electronic pump (Automed 3200; Ace Medical, Seoul, South Korea) is used for PCA&#xD;
           with demand bolus of 1 ml, background infusion of 1 ml/h and lock-out time of 15 min.&#xD;
           The concentration of oxycodone in IV PCA bag is 1 mg/ml, and the volume of&#xD;
           oxycodone-normal saline mixture delivered to patients for approximately 4 days is 200&#xD;
           ml.&#xD;
&#xD;
        -  Rocuronium infusions are discontinued after deflation of CO2.&#xD;
&#xD;
        -  After the end of surgery, a single intravenous bolus dose of sugammadex 2 or 4 mg/kg was&#xD;
           administered for reversal of moderate and deep NMB, respectively.&#xD;
&#xD;
        -  After the end of surgery, patients were taken to the PACU, and assessed for pain every&#xD;
           10 min using a VAS (0=no pain; 10=the most severe pain).&#xD;
&#xD;
        -  Researchers who evaluate postoperative pain will be blinded to the patient's allocation&#xD;
&#xD;
        -  Pain was measured at rest and when the wound areas were compressed with a force of 20 N&#xD;
           (i.e., 2 kg of pressure imposed by three fingers on a 10 cm2 area). The wound&#xD;
           compression was performed by a blinded researcher who was trained with an algometer&#xD;
           (Commander Algometer, J Tech Medical Industries, Midvale, UT, USA) to apply this force&#xD;
           consistently.&#xD;
&#xD;
        -  The patient was administered intravenous oxycodone 2 mg (body weight &lt;80 kg) or 3 mg&#xD;
           (&gt;80 kg) every 10 min until the VAS assessments showed that the pain intensity had&#xD;
           decreased to &lt;3 at rest and &lt;5 on wound compression. At this point, MEAD of oxycodone&#xD;
           was determined.&#xD;
&#xD;
        -  VAS for wound and shoulder pain were also assessed at 6 and 24 h after the end of&#xD;
           surgery.&#xD;
&#xD;
        -  Postoperative nausea and vomiting were evaluated using the Rhodes index of nausea&#xD;
           vomiting retching (RINVR) at 6 and 24 h after the end of surgery (Lee et al., 2016).&#xD;
&#xD;
        -  After the end of surgery, the surgeon scored the surgical working conditions according&#xD;
           to a five-point ordinal scale ranging from 1 (extremely poor conditions) to 5 (optimal&#xD;
           conditions) (Martini et al., 2014).&#xD;
&#xD;
        -  If the surgeon requests blind cessation for patient safety reasons, blindness is lifted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2018</start_date>
  <completion_date type="Actual">November 2, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This study is investigator-initiated, randomized, double blinded clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Researchers who evaluate postoperative pain will be blinded to the patient's allocation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)</measure>
    <time_frame>Through study period in PACU (post anesthesia care unit), up to 2 hours</time_frame>
    <description>The patient was administered intravenous oxycodone 2 mg (body weight &lt;80 kg) or 3 mg (&gt;80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to &lt;3 at rest and &lt;5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)</measure>
    <time_frame>Through study period in post anesthesia care unit (PACU), an average of about 1 hour</time_frame>
    <description>The patient was administered intravenous oxycodone 2 mg (body weight &lt;80 kg) or 3 mg (&gt;80 kg) every 10 min until the visual analogue scale (VAS) assessments showed that the pain intensity had decreased to &lt;3 at rest and &lt;5 on wound compression. At this point, the minimum effective analgesic dose (MEAD) of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>Deep NMB using rocuronium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate NMB using rocuronium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deep NMB using rocuronium</intervention_name>
    <description>Drug: rocuronium&#xD;
Bolus dose: 0.7 mg/kg&#xD;
Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.</description>
    <arm_group_label>Deep NMB using rocuronium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moderate NMB using rocuronium</intervention_name>
    <description>Drug: rocuronium&#xD;
Bolus dose: none&#xD;
Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.</description>
    <arm_group_label>Moderate NMB using rocuronium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 20 to 65 years old&#xD;
&#xD;
          -  American Society of Anesthesiologist Physical Status 1, 2 or 3&#xD;
&#xD;
          -  Patients undergoing laparoscopic gastrectomy&#xD;
&#xD;
          -  Patients who signed a written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive urine pregnancy test&#xD;
&#xD;
          -  Patients with known hypersensitivity to rocuronium or sugammadex&#xD;
&#xD;
          -  Patient with VAS score (0=no pain; 100=the most severe pain) of at least 10 before&#xD;
             surgery&#xD;
&#xD;
          -  Patients with liver cirrhosis confirmed by abdominal CT&#xD;
&#xD;
          -  Patients with neuromuscular disease that may interfere with neuromuscular data (ex.&#xD;
             Duchenne muscular dystrophy, myasthenia gravis)&#xD;
&#xD;
          -  Clinically significant impairment of cardiovascular function, defined by ejection&#xD;
             fraction &lt; 50%&#xD;
&#xD;
          -  Clinically significant impairment of renal function, defined by estimated GFR &lt; 60&#xD;
             ml/min or need for hemodialysis&#xD;
&#xD;
          -  Clinically significant impairment of liver function, defined by alanine&#xD;
             aminotransferase &gt; 100 IU/L&#xD;
&#xD;
          -  Indication for rapid sequence induction&#xD;
&#xD;
          -  Use of opioids within the 7 days prior to surgery&#xD;
&#xD;
          -  History of abdominal surgery&#xD;
&#xD;
          -  History of chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 35 kg/m2&#xD;
&#xD;
          -  Body weight &lt; 50 kg&#xD;
&#xD;
          -  Conversion to laparotomy&#xD;
&#xD;
          -  Family history of malignant hyperthermia&#xD;
&#xD;
          -  Patients who are considered by the investigator to be unsuitable to participate in the&#xD;
             study for any other reason not mentioned in the inclusion and exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byung-Moon Choi, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Pain Medicine, Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <results_first_submitted>July 29, 2019</results_first_submitted>
  <results_first_submitted_qc>October 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2019</results_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Byung-Moon Choi</investigator_full_name>
    <investigator_title>Associate Profesor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Because MSD provides research funding, the IPD of this study will not be shared with other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03266419/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Deep NMB Using Rocuronium</title>
          <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation&#xD;
Deep NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: 0.7 mg/kg&#xD;
Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.</description>
        </group>
        <group group_id="P2">
          <title>Moderate NMB Using Rocuronium</title>
          <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation&#xD;
Moderate NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: none&#xD;
Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Deep NMB Using Rocuronium</title>
          <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation&#xD;
Deep NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: 0.7 mg/kg&#xD;
Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.</description>
        </group>
        <group group_id="B2">
          <title>Moderate NMB Using Rocuronium</title>
          <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation&#xD;
Moderate NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: none&#xD;
Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.</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="51"/>
            <count group_id="B2" value="49"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="49"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" lower_limit="49" upper_limit="63"/>
                    <measurement group_id="B2" value="58" lower_limit="51" upper_limit="61"/>
                    <measurement group_id="B3" value="58" lower_limit="51" upper_limit="62"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="49"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>South Korea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="49"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of pneumoperitoneum</title>
          <description>Time taken to maintain pneumoperitoneum during operation (minute)</description>
          <units>minute</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="49"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117.0" lower_limit="91.8" upper_limit="137.5"/>
                    <measurement group_id="B2" value="102.0" lower_limit="88.0" upper_limit="120.5"/>
                    <measurement group_id="B3" value="109" lower_limit="89" upper_limit="131.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)</title>
        <description>The patient was administered intravenous oxycodone 2 mg (body weight &lt;80 kg) or 3 mg (&gt;80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to &lt;3 at rest and &lt;5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).</description>
        <time_frame>Through study period in PACU (post anesthesia care unit), up to 2 hours</time_frame>
        <population>patients undergoing elective laparoscopic gastrectomy</population>
        <group_list>
          <group group_id="O1">
            <title>Deep NMB Using Rocuronium</title>
            <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation&#xD;
Deep NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: 0.7 mg/kg&#xD;
Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.</description>
          </group>
          <group group_id="O2">
            <title>Moderate NMB Using Rocuronium</title>
            <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation&#xD;
Moderate NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: none&#xD;
Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)</title>
          <description>The patient was administered intravenous oxycodone 2 mg (body weight &lt;80 kg) or 3 mg (&gt;80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to &lt;3 at rest and &lt;5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).</description>
          <population>patients undergoing elective laparoscopic gastrectomy</population>
          <units>mg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="2" upper_limit="26"/>
                    <measurement group_id="O2" value="8.0" lower_limit="2" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)</title>
        <description>The patient was administered intravenous oxycodone 2 mg (body weight &lt;80 kg) or 3 mg (&gt;80 kg) every 10 min until the visual analogue scale (VAS) assessments showed that the pain intensity had decreased to &lt;3 at rest and &lt;5 on wound compression. At this point, the minimum effective analgesic dose (MEAD) of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).</description>
        <time_frame>Through study period in post anesthesia care unit (PACU), an average of about 1 hour</time_frame>
        <population>patients undergoing elective laparoscopic gastrectomy</population>
        <group_list>
          <group group_id="O1">
            <title>Deep NMB Using Rocuronium</title>
            <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation&#xD;
Deep NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: 0.7 mg/kg&#xD;
Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.</description>
          </group>
          <group group_id="O2">
            <title>Moderate NMB Using Rocuronium</title>
            <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation&#xD;
Moderate NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: none&#xD;
Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)</title>
          <description>The patient was administered intravenous oxycodone 2 mg (body weight &lt;80 kg) or 3 mg (&gt;80 kg) every 10 min until the visual analogue scale (VAS) assessments showed that the pain intensity had decreased to &lt;3 at rest and &lt;5 on wound compression. At this point, the minimum effective analgesic dose (MEAD) of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).</description>
          <population>patients undergoing elective laparoscopic gastrectomy</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="2.8" upper_limit="8.4"/>
                    <measurement group_id="O2" value="6.1" lower_limit="2.7" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>postoperative 24 h</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Deep NMB Using Rocuronium</title>
          <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation&#xD;
Deep NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: 0.7 mg/kg&#xD;
Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.</description>
        </group>
        <group group_id="E2">
          <title>Moderate NMB Using Rocuronium</title>
          <description>The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation&#xD;
Moderate NMB using rocuronium: - Drug: rocuronium&#xD;
Bolus dose: none&#xD;
Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </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>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>
    <limitations_and_caveats>Pain assessment was performed only until 24 h after the end of surgery.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Byung-Moon Choi</name_or_title>
      <organization>Asan Medical Center</organization>
      <phone>82-2-3010-1704</phone>
      <email>byungmoonchoi7@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/NCT03266419
org study id: 2017-0966
nct id: NCT03266419
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the influence of depth of neuromuscular blockade during
      laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to
      either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum
      of 13 mmHg.
-  All patients were fasted from midnight without premedication

        -  Once in the operating room, the patients were monitored using electrocardiography, pulse
           oximetry, end-tidal carbon dioxide partial pressure, non-invasive blood pressure, and
           bispectral index (Aspect 2000; Aspect Medical Systems, Inc., Newton, MA, USA)
           measurements.

        -  Neuromuscular transmission was monitored using the M-NMT® module at the adductor
           pollicis muscle (Carescape® B850, GE Healthcare, Milwaukee, WI, USA).

        -  Throughout the surgery, these data were continuously downloaded to personal computers by
           using RS232C cables.

        -  Following pre-oxygenation with 100% O2, anesthesia was induced with propofol and
           remifentanil, which were administered using a target effect-site
           concentration-controlled infusion pump (Perfusor® Space, B. Braun Melsungen, Germany) by
           using the models suggested by Schnider et al. and Minto et al (Minto et al., 1997;
           Schnider et al., 1998).

        -  Tracheal intubation was facilitated with rocuronium 0.6 mg/kg.

        -  After tracheal intubation, the lungs of the patients were then ventilated with oxygen in
           air (1:1) and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide
           partial pressure between 35 and 45 mmHg.

        -  For deep NMB group, an intravenous bolus of rocuronium (0.7 mg/kg) was given 2 minutes
           after intubation, followed by a continuous infusion of rocuronium of 0.8-1.2 mg/kg/h for
           maintaining deep NMB (post tetanic count 1-2) during operation. PTC was measured every 5
           minutes. In the case of deviations from the target PTC, the pump speed could be
           increased or decreased or a bolus dose (10 mg) could be given.

        -  For moderate NMB group, no further loading dose of rocuronium was given. An intravenous
           infusion with rocuronium (0.2-0.6 mg/kg/h) was started at a TOF count of 1 for
           maintaining moderate NMB (train of four 1-2) during operation. TOF was measured every 5
           minutes. In the case of deviations from the target TOF, the pump speed could be
           increased or decreased or a bolus dose (10 mg) could be given.

        -  The target effect-site concentrations of propofol were adjusted within a range of 2.5-3
           μg/ml to maintain the bispectral index values at less than 60 during the induction and
           maintenance of anesthesia.

        -  The target effect-site concentrations of remifentanil were titrated to prevent signs of
           inadequate anesthesia and to maintain stable hemodynamics (SBP > 80 mmHg and HR > 45
           beats/min).

           • Signs of inadequate anesthesia: systemic arterial blood pressure increased to greater
           than 15 mm Hg higher than the patient's normal value; heart rate exceeding 90 beats/min
           in the absence of hypovolemia; somatic responses, such as body movements (minimal muscle
           paralysis allowed physical movement), swallowing, coughing, grimacing, or opening of the
           eyes; and autonomic signs of inadequate anesthesia (Ausems, Vuyk, Hug, & Stanski, 1988)

        -  If necessary, ephedrine or atropine is administered to maintain systolic blood pressure
           above 80 mmHg and heart rate above 45 beats/min during anesthesia.

        -  An abdominal pressure of 13 mmHg was maintained during the laparoscopic surgery.

        -  When the surgeon asks for muscle relaxation due to the inability to obtain a visible
           laparoscopic field, additional bolus dose of rocuronium (10 mg) should be given.

        -  All patients were administered a bolus dose of oxycodone of 0.05 mg/kg at the end of
           pneumoperitoneum.

        -  IV PCA with oxycodone is started after the administration of loading dose. A
           semi-electronic pump (Automed 3200; Ace Medical, Seoul, South Korea) is used for PCA
           with demand bolus of 1 ml, background infusion of 1 ml/h and lock-out time of 15 min.
           The concentration of oxycodone in IV PCA bag is 1 mg/ml, and the volume of
           oxycodone-normal saline mixture delivered to patients for approximately 4 days is 200
           ml.

        -  Rocuronium infusions are discontinued after deflation of CO2.

        -  After the end of surgery, a single intravenous bolus dose of sugammadex 2 or 4 mg/kg was
           administered for reversal of moderate and deep NMB, respectively.

        -  After the end of surgery, patients were taken to the PACU, and assessed for pain every
           10 min using a VAS (0=no pain; 10=the most severe pain).

        -  Researchers who evaluate postoperative pain will be blinded to the patient's allocation

        -  Pain was measured at rest and when the wound areas were compressed with a force of 20 N
           (i.e., 2 kg of pressure imposed by three fingers on a 10 cm2 area). The wound
           compression was performed by a blinded researcher who was trained with an algometer
           (Commander Algometer, J Tech Medical Industries, Midvale, UT, USA) to apply this force
           consistently.

        -  The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg
           (>80 kg) every 10 min until the VAS assessments showed that the pain intensity had
           decreased to <3 at rest and <5 on wound compression. At this point, MEAD of oxycodone
           was determined.

        -  VAS for wound and shoulder pain were also assessed at 6 and 24 h after the end of
           surgery.

        -  Postoperative nausea and vomiting were evaluated using the Rhodes index of nausea
           vomiting retching (RINVR) at 6 and 24 h after the end of surgery (Lee et al., 2016).

        -  After the end of surgery, the surgeon scored the surgical working conditions according
           to a five-point ordinal scale ranging from 1 (extremely poor conditions) to 5 (optimal
           conditions) (Martini et al., 2014).

        -  If the surgeon requests blind cessation for patient safety reasons, blindness is lifted.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is investigator-initiated, randomized, double blinded clinical trial.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Researchers who evaluate postoperative pain will be blinded to the patient's allocation
measure: Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)
time frame: Through study period in PACU (post anesthesia care unit), up to 2 hours
description: The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).
measure: Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)
time frame: Through study period in post anesthesia care unit (PACU), an average of about 1 hour
description: The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the visual analogue scale (VAS) assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, the minimum effective analgesic dose (MEAD) of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).
arm group label: Deep NMB using rocuronium
arm group type: Experimental
description: The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation
arm group label: Moderate NMB using rocuronium
arm group type: Active Comparator
description: The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation
intervention type: Drug
intervention name: Deep NMB using rocuronium
description: Drug: rocuronium
Bolus dose: 0.7 mg/kg
Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.
arm group label: Deep NMB using rocuronium
intervention type: Drug
intervention name: Moderate NMB using rocuronium
description: Drug: rocuronium
Bolus dose: none
Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.
arm group label: Moderate NMB using rocuronium
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Byung-Moon Choi, Dr
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine, Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Byung-Moon Choi
investigator title: Associate Profesor
mesh term: Rocuronium
sharing ipd: No
ipd description: Because MSD provides research funding, the IPD of this study will not be shared with other researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Pain assessment was performed only until 24 h after the end of surgery.
point of contact: 