<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/NCT02249585</url>
  </required_header>
  <id_info>
    <org_study_id>1405-010-576</org_study_id>
    <nct_id>NCT02249585</nct_id>
  </id_info>
  <brief_title>Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out the effect of low abdominal pressure vs. standard&#xD;
      abdominal pressure on the cardiac and respiratory function of the patients undergoing&#xD;
      laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the&#xD;
      effect of the degree of neuromuscular blockade on the surgical condition of the patients&#xD;
      undergoing laparoscopic colon surgery in Trendelenberg position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Index</measure>
    <time_frame>30 min after onset of laparoscopy</time_frame>
    <description>Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Blood Pressure (MBP)</measure>
    <time_frame>1, 30, 60, 90, and 120 minutes after onset of laparoscopy</time_frame>
    <description>Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Volume Index (SVI)</measure>
    <time_frame>1, 30, 60, 90, 120 min after onset of laparoscopy</time_frame>
    <description>Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2</measure>
    <time_frame>1, 30, 60, 90, and 120 minutes after onset of laparoscopy</time_frame>
    <description>PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Compliance</measure>
    <time_frame>1, 30, 60, 90, and 120 minutes after onset of laparoscopy</time_frame>
    <description>Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Rating Scale</measure>
    <time_frame>1 min after laparoscopic procedure</time_frame>
    <description>The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Cardiac Index</condition>
  <arm_group>
    <arm_group_label>CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard abdominal pressure</intervention_name>
    <description>Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery</description>
    <arm_group_label>CS</arm_group_label>
    <arm_group_label>DS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low abdominal pressure</intervention_name>
    <description>Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery</description>
    <arm_group_label>DL</arm_group_label>
    <other_name>Abdominal pressure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional neuromuscular blockade</intervention_name>
    <description>Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
    <arm_group_label>CS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deep neuromuscular blockade</intervention_name>
    <description>Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
    <arm_group_label>DL</arm_group_label>
    <arm_group_label>DS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for laparoscopic colon surgery under Trendelenberg position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA classification IV&#xD;
&#xD;
          -  Unable to make a written, informed consent&#xD;
&#xD;
          -  Allergic to neuromuscular blocking agents, anesthetics, opioids&#xD;
&#xD;
          -  Patients with neuromuscular disease&#xD;
&#xD;
          -  Hepatic failure&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  History of malignant hyperthermia&#xD;
&#xD;
          -  Morbid obesity with BMI&gt;35 kg/m2&#xD;
&#xD;
          -  Patients enrolled in another clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>May 31, 2017</results_first_submitted>
  <results_first_submitted_qc>November 9, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 6, 2018</results_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Kook Hyun Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CS(Conventional Block With Standard Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
        </group>
        <group group_id="P2">
          <title>DS(Deep Block With Standard Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
        </group>
        <group group_id="P3">
          <title>DL(Deep Block With Low Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CS(Conventional Block With Standard Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
        </group>
        <group group_id="B2">
          <title>DS(Deep Block With Standard Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
        </group>
        <group group_id="B3">
          <title>DL(Deep Block With Low Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
        </group>
        <group group_id="B4">
          <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="43"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="131"/>
          </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="67" spread="12"/>
                    <measurement group_id="B2" value="64" spread="11"/>
                    <measurement group_id="B3" value="62" spread="11"/>
                    <measurement group_id="B4" value="65" spread="12"/>
                  </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="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cardiac Index</title>
        <description>Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</description>
        <time_frame>30 min after onset of laparoscopy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CS(Conventional Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
          </group>
          <group group_id="O2">
            <title>DS(Deep Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
          <group group_id="O3">
            <title>DL(Deep Block With Low Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Index</title>
          <description>Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</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="43"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.0"/>
                    <measurement group_id="O2" value="2.7" spread="0.9"/>
                    <measurement group_id="O3" value="2.7" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Arterial Blood Pressure (MBP)</title>
        <description>Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</description>
        <time_frame>1, 30, 60, 90, and 120 minutes after onset of laparoscopy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CS(Conventional Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
          </group>
          <group group_id="O2">
            <title>DS(Deep Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
          <group group_id="O3">
            <title>DL(Deep Block With Low Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Arterial Blood Pressure (MBP)</title>
          <description>Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</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="43"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MBP 1 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" spread="13"/>
                    <measurement group_id="O2" value="92" spread="12"/>
                    <measurement group_id="O3" value="90" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MBP 30 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" spread="10"/>
                    <measurement group_id="O2" value="92" spread="14"/>
                    <measurement group_id="O3" value="91" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MBP 60 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" spread="11"/>
                    <measurement group_id="O2" value="90" spread="14"/>
                    <measurement group_id="O3" value="89" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MBP 90 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="11"/>
                    <measurement group_id="O2" value="89" spread="10"/>
                    <measurement group_id="O3" value="88" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MBP 120 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="13"/>
                    <measurement group_id="O2" value="90" spread="10"/>
                    <measurement group_id="O3" value="88" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stroke Volume Index (SVI)</title>
        <description>Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</description>
        <time_frame>1, 30, 60, 90, 120 min after onset of laparoscopy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CS(Conventional Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
          </group>
          <group group_id="O2">
            <title>DS(Deep Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
          <group group_id="O3">
            <title>DL(Deep Block With Low Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
        </group_list>
        <measure>
          <title>Stroke Volume Index (SVI)</title>
          <description>Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.</description>
          <units>mL/beat/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="43"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SVI 1 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" spread="9"/>
                    <measurement group_id="O2" value="41" spread="12"/>
                    <measurement group_id="O3" value="38" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVI 30 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="10"/>
                    <measurement group_id="O2" value="42" spread="12"/>
                    <measurement group_id="O3" value="40" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVI 60 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" spread="12"/>
                    <measurement group_id="O2" value="42" spread="12"/>
                    <measurement group_id="O3" value="40" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVI 90 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="9"/>
                    <measurement group_id="O2" value="41" spread="11"/>
                    <measurement group_id="O3" value="39" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVI 120 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="9"/>
                    <measurement group_id="O2" value="40" spread="12"/>
                    <measurement group_id="O3" value="39" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PaO2</title>
        <description>PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).</description>
        <time_frame>1, 30, 60, 90, and 120 minutes after onset of laparoscopy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CS(Conventional Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
          </group>
          <group group_id="O2">
            <title>DS(Deep Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
          <group group_id="O3">
            <title>DL(Deep Block With Low Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
        </group_list>
        <measure>
          <title>PaO2</title>
          <description>PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).</description>
          <units>kPa</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PaO2 1 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="7"/>
                    <measurement group_id="O2" value="26" spread="7"/>
                    <measurement group_id="O3" value="27" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PaO2 30 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="7"/>
                    <measurement group_id="O2" value="26" spread="6"/>
                    <measurement group_id="O3" value="27" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PaO2 60 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="6"/>
                    <measurement group_id="O2" value="26" spread="7"/>
                    <measurement group_id="O3" value="26" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PaO2 90 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="6"/>
                    <measurement group_id="O2" value="28" spread="5"/>
                    <measurement group_id="O3" value="25" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PaO2 120 min after onset of laparoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="6"/>
                    <measurement group_id="O2" value="28" spread="5"/>
                    <measurement group_id="O3" value="25" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pulmonary Compliance</title>
        <description>Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).</description>
        <time_frame>1, 30, 60, 90, and 120 minutes after onset of laparoscopy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CS(Conventional Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
          </group>
          <group group_id="O2">
            <title>DS(Deep Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
          <group group_id="O3">
            <title>DL(Deep Block With Low Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
        </group_list>
        <measure>
          <title>Pulmonary Compliance</title>
          <description>Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).</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="43"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Compliance 1 min after onset of laparoscop</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" spread="7"/>
                    <measurement group_id="O2" value="29" spread="9"/>
                    <measurement group_id="O3" value="34" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Compliance 30 min after onset of laparoscop</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" spread="6"/>
                    <measurement group_id="O2" value="25" spread="5"/>
                    <measurement group_id="O3" value="28" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Compliance 60 min after onset of laparoscop</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="6"/>
                    <measurement group_id="O2" value="25" spread="6"/>
                    <measurement group_id="O3" value="29" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Compliance 90 min after onset of laparoscop</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="7"/>
                    <measurement group_id="O2" value="25" spread="8"/>
                    <measurement group_id="O3" value="28" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Compliance 120 min after onset of laparoscop</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="7"/>
                    <measurement group_id="O2" value="28" spread="6"/>
                    <measurement group_id="O3" value="30" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgical Rating Scale</title>
        <description>The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.</description>
        <time_frame>1 min after laparoscopic procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CS(Conventional Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
          </group>
          <group group_id="O2">
            <title>DS(Deep Block With Standard Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
          <group group_id="O3">
            <title>DL(Deep Block With Low Pressure)</title>
            <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Rating Scale</title>
          <description>The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Optimal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Acceptable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extremely poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>CS(Conventional Block With Standard Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch</description>
        </group>
        <group group_id="E2">
          <title>DS(Deep Block With Standard Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.&#xD;
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</description>
        </group>
        <group group_id="E3">
          <title>DL(Deep Block With Low Pressure)</title>
          <description>Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.&#xD;
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery&#xD;
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch</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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr Kook Hyun Lee, MD, PhD</name_or_title>
      <organization>Seoul National University Hospital</organization>
      <phone>82-2-2072-2467</phone>
      <email>leekh@snu.ac.kr</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/NCT02249585
org study id: 1405-010-576
nct id: NCT02249585
lead sponsor: 
The purpose of this study is to find out the effect of low abdominal pressure vs. standard
      abdominal pressure on the cardiac and respiratory function of the patients undergoing
      laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the
      effect of the degree of neuromuscular blockade on the surgical condition of the patients
      undergoing laparoscopic colon surgery in Trendelenberg position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Cardiac Index
time frame: 30 min after onset of laparoscopy
description: Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
measure: Mean Arterial Blood Pressure (MBP)
time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
description: Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
measure: Stroke Volume Index (SVI)
time frame: 1, 30, 60, 90, 120 min after onset of laparoscopy
description: Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
measure: PaO2
time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
description: PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).
measure: Pulmonary Compliance
time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
description: Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).
measure: Surgical Rating Scale
time frame: 1 min after laparoscopic procedure
description: The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.
arm group label: CS
arm group type: Experimental
description: Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
arm group label: DS
arm group type: Experimental
description: Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
arm group label: DL
arm group type: Experimental
description: Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
intervention type: Device
intervention name: Standard abdominal pressure
description: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery
arm group label: CS
arm group label: DS
intervention type: Device
intervention name: Low abdominal pressure
description: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery
arm group label: DL
other name: Abdominal pressure
intervention type: Drug
intervention name: Conventional neuromuscular blockade
description: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch
arm group label: CS
intervention type: Drug
intervention name: Deep neuromuscular blockade
description: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch
arm group label: DL
arm group label: DS
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kook Hyun Lee
investigator title: Professor
mesh term: Iodine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 