<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/NCT01722097</url>
  </required_header>
  <id_info>
    <org_study_id>NMBDK2012</org_study_id>
    <secondary_id>2012-003787-51</secondary_id>
    <nct_id>NCT01722097</nct_id>
  </id_info>
  <brief_title>Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure</brief_title>
  <official_title>Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain.&#xD;
      Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure&#xD;
      (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).&#xD;
&#xD;
      Primary hypothesis:&#xD;
&#xD;
      Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative&#xD;
      pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder Pain</measure>
    <time_frame>within 14 days</time_frame>
    <description>Number of participants with shoulder pain or discomfort (VAS &gt; 20) in the shoulder region within 14 days after operation.&#xD;
VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)</measure>
    <time_frame>within 14 days</time_frame>
    <description>Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.&#xD;
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.&#xD;
Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient-movements</measure>
    <time_frame>During surgery</time_frame>
    <description>Number of unintended and unwanted patient-movements registered by the surgeon</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <condition>Pain</condition>
  <condition>Laparoscopy</condition>
  <arm_group>
    <arm_group_label>Deep neuromuscular blockade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate neuromuscular blockade</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <arm_group_label>Deep neuromuscular blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Moderate neuromuscular blockade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective laparoscopic hysterectomy (total/subtotal)&#xD;
&#xD;
          -  Can read and understand Danish&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 30 kg/cm2&#xD;
&#xD;
          -  Known allergy to medications that are included in the project&#xD;
&#xD;
          -  Severe renal disease, defined by S-creatinine &gt; 0,200 mmol/L, GFR &lt; 30ml/min or&#xD;
             hemodialysis)&#xD;
&#xD;
          -  Neuromuscular disease that may interfere with neuromuscular data&#xD;
&#xD;
          -  Lactating&#xD;
&#xD;
          -  Impaired liver function&#xD;
&#xD;
          -  Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mona Gätke, MD, ph.d.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of anesthesia, Herlev Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matias Vested Maden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of anesthesia, Herlev Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet</name>
      <address>
        <city>Søborg</city>
        <zip>2830</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>August 18, 2015</results_first_submitted>
  <results_first_submitted_qc>September 21, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 21, 2015</results_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Matias Vested Madsen</investigator_full_name>
    <investigator_title>research assistent, MD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Deep Neuromuscular Blockade</title>
          <description>Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron&#xD;
Rocuronium</description>
        </group>
        <group group_id="P2">
          <title>Moderate Neuromuscular Blockade</title>
          <description>Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron&#xD;
placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Patient sheets not returned</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Deep Neuromuscular Blockade</title>
          <description>Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron&#xD;
Rocuronium</description>
        </group>
        <group group_id="B2">
          <title>Moderate Neuromuscular Blockade</title>
          <description>Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron&#xD;
placebo</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="55"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="110"/>
          </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="47" spread="5"/>
                    <measurement group_id="B2" value="48" spread="5"/>
                    <measurement group_id="B3" value="47" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>In total 110 women participated in the study</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>women</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="110"/>
                  </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>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.1" spread="3.0"/>
                    <measurement group_id="B2" value="24.2" spread="3.1"/>
                    <measurement group_id="B3" value="23.6" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologists Physical Status Classification 1</title>
          <description>American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM 1-6.&#xD;
A normal healthy patient&#xD;
A patient with mild systemic disease&#xD;
A patient with severe systemic disease&#xD;
A patient with severe systemic disease that is a constant threat to life&#xD;
A moribund patient who is not expected to survive without the operation&#xD;
A declared brain-dead patient whose organs are being removed for donor purposes</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity (full term pregnancies)</title>
          <units>pregnancies</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B2" value="2" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B3" value="2" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous abdominal surgery</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subtotal hysterectomy</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologists Physical Status Classification 2</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total hysterectomy</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Shoulder Pain</title>
        <description>Number of participants with shoulder pain or discomfort (VAS &gt; 20) in the shoulder region within 14 days after operation.&#xD;
VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).</description>
        <time_frame>within 14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade</title>
            <description>Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron&#xD;
Rocuronium</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade</title>
            <description>Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron&#xD;
placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Shoulder Pain</title>
          <description>Number of participants with shoulder pain or discomfort (VAS &gt; 20) in the shoulder region within 14 days after operation.&#xD;
VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)</title>
        <description>Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.&#xD;
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.&#xD;
Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery.</description>
        <time_frame>within 14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade</title>
            <description>Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron&#xD;
Rocuronium</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade</title>
            <description>Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron&#xD;
placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)</title>
          <description>Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.&#xD;
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.&#xD;
Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery.</description>
          <units>units on a scale*days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VAS shoulder pain 4 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" lower_limit="5.8" upper_limit="44.7"/>
                    <measurement group_id="O2" value="28.5" lower_limit="6.3" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS shoulder pain 14 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6" lower_limit="8.2" upper_limit="67.9"/>
                    <measurement group_id="O2" value="36.3" lower_limit="9.7" upper_limit="86.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS incisional pain 4 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.4" lower_limit="33.8" upper_limit="189.3"/>
                    <measurement group_id="O2" value="102.2" lower_limit="35.8" upper_limit="159.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS incisional pain 14 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.6" lower_limit="62.0" upper_limit="291.6"/>
                    <measurement group_id="O2" value="150.8" lower_limit="56.8" upper_limit="306.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS abdominal pain 4 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.4" lower_limit="50.0" upper_limit="213.2"/>
                    <measurement group_id="O2" value="114.1" lower_limit="57.8" upper_limit="207.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS abdominal pain 14 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190.8" lower_limit="103.2" upper_limit="366.8"/>
                    <measurement group_id="O2" value="215.5" lower_limit="109.5" upper_limit="396.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS overall pain 4 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.7" lower_limit="51.9" upper_limit="200.8"/>
                    <measurement group_id="O2" value="129.8" lower_limit="79.0" upper_limit="198.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS overall pain 14 days AUC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190.2" lower_limit="118.9" upper_limit="402.5"/>
                    <measurement group_id="O2" value="256.9" lower_limit="121.3" upper_limit="403.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient-movements</title>
        <description>Number of unintended and unwanted patient-movements registered by the surgeon</description>
        <time_frame>During surgery</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Deep Neuromuscular Blockade</title>
          <description>Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron&#xD;
Rocuronium</description>
        </group>
        <group group_id="E2">
          <title>Moderate Neuromuscular Blockade</title>
          <description>Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron&#xD;
placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection after surgery</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Lesion of the bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Vesicovaginal fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Postoperative bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
              </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="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Matias Vested Madsen</name_or_title>
      <organization>Herlev Hospital, University of Copenhagen, Department of Anaesthesiology</organization>
      <phone>+45 38683868</phone>
      <email>matias.vested.madsen@regionh.dk</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/NCT01722097
org study id: NMBDK2012
secondary id: 2012-003787-51
nct id: NCT01722097
lead sponsor: 
has dmc: Yes
The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain.
      Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure
      (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

      Primary hypothesis:

      Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative
      pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Shoulder Pain
time frame: within 14 days
description: Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation.
VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).
measure: Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)
time frame: within 14 days
description: Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.
Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery.
measure: Patient-movements
time frame: During surgery
description: Number of unintended and unwanted patient-movements registered by the surgeon
arm group label: Deep neuromuscular blockade
arm group type: Active Comparator
description: Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
arm group label: Moderate neuromuscular blockade
arm group type: Placebo Comparator
description: Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
intervention type: Drug
intervention name: Rocuronium
arm group label: Deep neuromuscular blockade
intervention type: Drug
intervention name: placebo
arm group label: Moderate neuromuscular blockade
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mona Gätke, MD, ph.d.
role: Study Chair
affiliation: Department of anesthesia, Herlev Hospital
last name: Matias Vested Maden, MD
role: Principal Investigator
affiliation: Department of anesthesia, Herlev Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Matias Vested Madsen
investigator title: research assistent, MD
mesh term: Rocuronium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 