<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/NCT02247466</url>
  </required_header>
  <id_info>
    <org_study_id>NMBDKHernia2014</org_study_id>
    <nct_id>NCT02247466</nct_id>
  </id_info>
  <brief_title>Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade</brief_title>
  <official_title>Optimizing Surgical Conditions During Laparoscopic Umbilical, Incisional -and Linea Alba Herniotomy With Deep Neuromuscular Blockade</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 is to investigate surgical work space and surgical conditions in&#xD;
      patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The&#xD;
      patients will act as their own control with evaluation of surgical work space and surgical&#xD;
      conditions during both deep NMB and no NMB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Umbilical herniotomy is a frequent surgical procedure worldwide, and the larger hernia&#xD;
      defects are preferably operated by laparoscopic technique. The advantages of the laparoscopic&#xD;
      approach are shorter convalescence with earlier mobilization, and less wound complications&#xD;
      [1]. A preferred approach is currently to close the defect by laparoscopic suturing in order&#xD;
      to reduce the formation of seroma in the hernia sac [2] , and then apply a mesh by&#xD;
      intraperitoneal onlay technique (IPOM technique). However, it may be difficult to suture the&#xD;
      defect if there is tension in the abdominal wall muscles together with the applied&#xD;
      pneumoperitoneum.&#xD;
&#xD;
      There is evidence that muscle relaxation improves conditions for endotracheal intubation[3]&#xD;
      and reduces laryngeal morbidity but only a few studies investigate the necessity of&#xD;
      relaxation during laparoscopic surgery [4].&#xD;
&#xD;
      During laparoscopic surgery muscle relaxation is used with great variability. Sometimes the&#xD;
      procedure is performed without muscle relaxation and sometimes with a so-called surgical&#xD;
      neuromuscular blockade, which with objective neuromuscular monitoring means that&#xD;
      train-of-four (TOF) is kept at 3-4 responses to nerve stimulation of the ulnar nerve. In this&#xD;
      way there is a great variability in the neuromuscular blockade and rarely the patients are&#xD;
      receiving deep neuromuscular blockade.&#xD;
&#xD;
      Traditionally, neuromuscular monitoring is done by measuring the muscle strength of the&#xD;
      adductor pollicis muscle on the thumb. The response to TOF nerve stimulation may be zero,&#xD;
      while muscle relaxation of more resistant muscles such as the abdominal muscles and the&#xD;
      diaphragm [5;6] are not complete which means that the patients may cough and their abdominal&#xD;
      wall may feel &quot;tight&quot; during surgery, even though no response at the thumb is recorded. It is&#xD;
      possible to quantify a deep neuromuscular block by the use of post-tetanic-count (PTC). With&#xD;
      establishment of deep, continuous neuromuscular blockade with PTC value 0-1 all muscles&#xD;
      including abdominal muscles and diaphragm are paralyzed [7]. It is therefore possible, that a&#xD;
      deep neuromuscular blockade (NMB) where the diaphragm and the abdominal wall muscles are more&#xD;
      paralyzed will optimize the surgical work space, ease the surgical procedure, reduce&#xD;
      operative time for the suturing part of the procedure as well as the total procedure time,&#xD;
      and reduce the number of recurrences by long term follow-up.&#xD;
&#xD;
      The purpose of this study is to investigate surgical work space and surgical conditions in&#xD;
      patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The&#xD;
      patients will act as their own control with evaluation of surgical work space and surgical&#xD;
      conditions during both deep NMB and no NMB.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Deep NMB defined as TOF=0 and post-tetanic count PTC ≥1, will give better surgical workspace,&#xD;
      better surgical conditions, as well as shorter duration of surgery and reduced number of&#xD;
      recurrences of hernias compared with no NMB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">February 23, 2017</completion_date>
  <primary_completion_date type="Actual">February 23, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of Surgical Workspace</measure>
    <time_frame>3 hours</time_frame>
    <description>Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.&#xD;
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical Conditions While Suturing</measure>
    <time_frame>3 hours</time_frame>
    <description>Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale)&#xD;
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operating Time</measure>
    <time_frame>3 hours</time_frame>
    <description>Duration of operating time (from first incision to last suture)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suturing Time</measure>
    <time_frame>3 hours</time_frame>
    <description>Duration of suturing the hernia (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contractions</measure>
    <time_frame>3 hours</time_frame>
    <description>Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insufflator Alarms</measure>
    <time_frame>3 hours</time_frame>
    <description>Insufflator alarms where pneumoperitoneum &gt; 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum &gt; 17 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous Abdominal Contractions</measure>
    <time_frame>3 hours</time_frame>
    <description>Number of patients experiencing episodes with continuous abdominal contractions where the abdomen feels &quot;tight&quot; but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrences of Hernias</measure>
    <time_frame>2 years</time_frame>
    <description>Number of recurrences of hernias by 2 year follow-up (separate publication).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Laparoscopic Herniotomy</condition>
  <arm_group>
    <arm_group_label>Group A - Saline, assesment, rocuronium and assesment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Rocuronium, assesment, sugammadex and assesment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium and Sugammadex</intervention_name>
    <arm_group_label>Group A - Saline, assesment, rocuronium and assesment</arm_group_label>
    <arm_group_label>Group B - Rocuronium, assesment, sugammadex and assesment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years old&#xD;
&#xD;
          -  Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba -&#xD;
             herniotomy&#xD;
&#xD;
          -  Can read and understand Danish&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to sugammadex, rocuronium or mivacurium&#xD;
&#xD;
          -  Known homozygous variants in the butyrylcholinesterase gene&#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 or pregnant (Women of child bearing potential must take a urine pregnancy&#xD;
             test at the day of the operation. The test will be provided by the hospital staff).&#xD;
&#xD;
          -  Indication for rapid sequence induction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mona Ring Gätke, MD, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anaesthesiology, Herlev Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <state>Region Hovedstaden</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <state>Region Hovedstaden</state>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>October 2, 2018</results_first_submitted>
  <results_first_submitted_qc>June 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2019</results_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Roar Medici</investigator_full_name>
    <investigator_title>MD, research assistant</investigator_title>
  </responsible_party>
  <keyword>Neuromuscular Blockade</keyword>
  <keyword>Laparoscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <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>September 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT02247466/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
          <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
        </group>
        <group group_id="P2">
          <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
          <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Procedure changed to open surgery</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
          <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
        </group>
        <group group_id="B2">
          <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
          <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</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="19"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" spread="17"/>
                    <measurement group_id="B2" value="55" spread="15"/>
                    <measurement group_id="B3" value="56.4" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </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>BMI</title>
          <description>Body Mass Index</description>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" spread="4"/>
                    <measurement group_id="B2" value="30" spread="4"/>
                    <measurement group_id="B3" value="29" spread="4.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA 1/2/3</title>
          <description>american society of anesthesiologists Physical Status Classification System score.&#xD;
American Society of Anesthesiologists (ASA) Score is a global score that assesses the physical status of patients before surgery.&#xD;
It is sometimed refereed to as ASA-PS, because it is a measure of 'physical status'.&#xD;
ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive</description>
          <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="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ASA 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ASA 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ASA 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous abdominal surgery</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="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Herniea size (cm)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.4" spread="1.5"/>
                    <measurement group_id="B2" value="3.1" spread="2.1"/>
                    <measurement group_id="B3" value="2.72" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Improvement of Surgical Workspace</title>
        <description>Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.&#xD;
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)</description>
        <time_frame>3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of Surgical Workspace</title>
          <description>Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.&#xD;
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal 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="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Changes in ratings 5 to 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 4 to 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 5 to 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 3 to 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 4 to 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 5 to 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 4 to 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 3 to 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Changes in ratings 3 to 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgical Conditions While Suturing</title>
        <description>Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale)&#xD;
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)</description>
        <time_frame>3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Conditions While Suturing</title>
          <description>Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale)&#xD;
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal 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="19"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1. Extremely poor conditions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2. Poor conditions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3. Acceptable conditions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4. Good conditions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5. Optimal conditions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operating Time</title>
        <description>Duration of operating time (from first incision to last suture)</description>
        <time_frame>3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
        </group_list>
        <measure>
          <title>Operating Time</title>
          <description>Duration of operating time (from first incision to last suture)</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" lower_limit="37" upper_limit="85"/>
                    <measurement group_id="O2" value="64" lower_limit="33" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Suturing Time</title>
        <description>Duration of suturing the hernia (minutes)</description>
        <time_frame>3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
        </group_list>
        <measure>
          <title>Suturing Time</title>
          <description>Duration of suturing the hernia (minutes)</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="1" upper_limit="19"/>
                    <measurement group_id="O2" value="9" lower_limit="2" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Contractions</title>
        <description>Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions</description>
        <time_frame>3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
        </group_list>
        <measure>
          <title>Contractions</title>
          <description>Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions</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="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insufflator Alarms</title>
        <description>Insufflator alarms where pneumoperitoneum &gt; 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum &gt; 17 mmHg</description>
        <time_frame>3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
        </group_list>
        <measure>
          <title>Insufflator Alarms</title>
          <description>Insufflator alarms where pneumoperitoneum &gt; 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum &gt; 17 mmHg</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="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Continuous Abdominal Contractions</title>
        <description>Number of patients experiencing episodes with continuous abdominal contractions where the abdomen feels &quot;tight&quot; but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall)</description>
        <time_frame>3 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
            <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
          </group>
        </group_list>
        <measure>
          <title>Continuous Abdominal Contractions</title>
          <description>Number of patients experiencing episodes with continuous abdominal contractions where the abdomen feels &quot;tight&quot; but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall)</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="19"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrences of Hernias</title>
        <description>Number of recurrences of hernias by 2 year follow-up (separate publication).</description>
        <time_frame>2 years</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients will be observed during their stay at the hospital and will be contacted by telephone on first and seventh postoperative day. Possibly adverse events during this period will be reported. Finally the patient´s case files will be reviewed for reports of adverse events at 17-21 days after operation.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group A - Saline, Assesment, Rocuronium and Assesment</title>
          <description>Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</description>
        </group>
        <group group_id="E2">
          <title>Group B - Rocuronium, Assesment, Sugammadex and Assesment</title>
          <description>Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again&#xD;
Rocuronium and Sugammadex</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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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>Roar Borregaard Medici, MD, Research Assistant</name_or_title>
      <organization>Department of Anaesthesiology, Herlev Hospital, University of Copenhagen</organization>
      <phone>+4526390068</phone>
      <email>roar.borregaard.medici.01@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/NCT02247466
org study id: NMBDKHernia2014
nct id: NCT02247466
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate surgical work space and surgical conditions in
      patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The
      patients will act as their own control with evaluation of surgical work space and surgical
      conditions during both deep NMB and no NMB.
Umbilical herniotomy is a frequent surgical procedure worldwide, and the larger hernia
      defects are preferably operated by laparoscopic technique. The advantages of the laparoscopic
      approach are shorter convalescence with earlier mobilization, and less wound complications
      [1]. A preferred approach is currently to close the defect by laparoscopic suturing in order
      to reduce the formation of seroma in the hernia sac [2] , and then apply a mesh by
      intraperitoneal onlay technique (IPOM technique). However, it may be difficult to suture the
      defect if there is tension in the abdominal wall muscles together with the applied
      pneumoperitoneum.

      There is evidence that muscle relaxation improves conditions for endotracheal intubation[3]
      and reduces laryngeal morbidity but only a few studies investigate the necessity of
      relaxation during laparoscopic surgery [4].

      During laparoscopic surgery muscle relaxation is used with great variability. Sometimes the
      procedure is performed without muscle relaxation and sometimes with a so-called surgical
      neuromuscular blockade, which with objective neuromuscular monitoring means that
      train-of-four (TOF) is kept at 3-4 responses to nerve stimulation of the ulnar nerve. In this
      way there is a great variability in the neuromuscular blockade and rarely the patients are
      receiving deep neuromuscular blockade.

      Traditionally, neuromuscular monitoring is done by measuring the muscle strength of the
      adductor pollicis muscle on the thumb. The response to TOF nerve stimulation may be zero,
      while muscle relaxation of more resistant muscles such as the abdominal muscles and the
      diaphragm [5;6] are not complete which means that the patients may cough and their abdominal
      wall may feel "tight" during surgery, even though no response at the thumb is recorded. It is
      possible to quantify a deep neuromuscular block by the use of post-tetanic-count (PTC). With
      establishment of deep, continuous neuromuscular blockade with PTC value 0-1 all muscles
      including abdominal muscles and diaphragm are paralyzed [7]. It is therefore possible, that a
      deep neuromuscular blockade (NMB) where the diaphragm and the abdominal wall muscles are more
      paralyzed will optimize the surgical work space, ease the surgical procedure, reduce
      operative time for the suturing part of the procedure as well as the total procedure time,
      and reduce the number of recurrences by long term follow-up.

      The purpose of this study is to investigate surgical work space and surgical conditions in
      patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The
      patients will act as their own control with evaluation of surgical work space and surgical
      conditions during both deep NMB and no NMB.

      Hypothesis:

      Deep NMB defined as TOF=0 and post-tetanic count PTC ≥1, will give better surgical workspace,
      better surgical conditions, as well as shorter duration of surgery and reduced number of
      recurrences of hernias compared with no NMB.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Improvement of Surgical Workspace
time frame: 3 hours
description: Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)
measure: Surgical Conditions While Suturing
time frame: 3 hours
description: Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale)
(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)
measure: Operating Time
time frame: 3 hours
description: Duration of operating time (from first incision to last suture)
measure: Suturing Time
time frame: 3 hours
description: Duration of suturing the hernia (minutes)
measure: Contractions
time frame: 3 hours
description: Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions
measure: Insufflator Alarms
time frame: 3 hours
description: Insufflator alarms where pneumoperitoneum > 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum > 17 mmHg
measure: Continuous Abdominal Contractions
time frame: 3 hours
description: Number of patients experiencing episodes with continuous abdominal contractions where the abdomen feels "tight" but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall)
measure: Recurrences of Hernias
time frame: 2 years
description: Number of recurrences of hernias by 2 year follow-up (separate publication).
arm group label: Group A - Saline, assesment, rocuronium and assesment
arm group type: Active Comparator
description: Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again
arm group label: Group B - Rocuronium, assesment, sugammadex and assesment
arm group type: Active Comparator
description: Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again
intervention type: Drug
intervention name: Rocuronium and Sugammadex
arm group label: Group A - Saline, assesment, rocuronium and assesment
arm group label: Group B - Rocuronium, assesment, sugammadex and assesment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mona Ring Gätke, MD, Ph.D.
role: Study Chair
affiliation: Department of Anaesthesiology, Herlev Hospital
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Roar Medici
investigator title: MD, research assistant
mesh term: Rocuronium
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 