<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/NCT02243943</url>
  </required_header>
  <id_info>
    <org_study_id>NL34186.058.10</org_study_id>
    <secondary_id>NL34186.058.10</secondary_id>
    <nct_id>NCT02243943</nct_id>
  </id_info>
  <brief_title>Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile</brief_title>
  <acronym>Neuropa</acronym>
  <official_title>Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leiden University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Suboptimal reversal of neuromuscular blockage after surgery is possibly related to&#xD;
      unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete&#xD;
      reversal of neuromuscular block was not possible untill sugammadex was discovered. The&#xD;
      investigators hyposthesise that reversal with sugammadex leads to favorable postoperative&#xD;
      respiratory conditions and less pain compared to reversal with neostigmine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Lowest Saturation</measure>
    <time_frame>45 minutes post surgery</time_frame>
    <description>Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>45 minutes post surgery</time_frame>
    <description>using the 1-10 numeric rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation</measure>
    <time_frame>45 minutes post surgery</time_frame>
    <description>using the Leiden observer alertness score (1 alert - 5 sedated)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Postoperative Respiratory Condition</condition>
  <arm_group>
    <arm_group_label>Sugammadex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>neostigmine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <arm_group_label>Sugammadex</arm_group_label>
    <other_name>Bridion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neostigmine</intervention_name>
    <arm_group_label>neostigmine</arm_group_label>
    <other_name>Prostigmin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years&#xD;
&#xD;
          -  - BMI &lt; 35&#xD;
&#xD;
          -  -ASA class I- III&#xD;
&#xD;
          -  -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's&#xD;
&#xD;
               -  Patients with ability to give oral and written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet the inclusion criteria&#xD;
&#xD;
               -  -Known or suspected neuromuscular disorders impairing neuromuscular function&#xD;
&#xD;
               -  -Allergies to muscle relaxants, anesthetics or narcotics&#xD;
&#xD;
          -  A (family) history of malignant hyperthermia&#xD;
&#xD;
               -  -Women who are or may be pregnant or are currently breast feeding&#xD;
&#xD;
               -  -Contraindications for the use of neostigmine&#xD;
&#xD;
          -  Intestinal obstruction,&#xD;
&#xD;
          -  COPD GOLD 4&#xD;
&#xD;
               -  -Abnormal heart rhythm (eg. bradycardia: &lt; 40/min);&#xD;
&#xD;
               -  -Surgery requiring neuraxial anesthesia / analgesia&#xD;
&#xD;
               -  -Preoperative cognitive dysfunction or mental disabilities&#xD;
&#xD;
               -  -Preexistent significant pulmonary disease with preoperative SpO2 &lt; 90%&#xD;
&#xD;
               -  -Preoperative ICU treatment / intubation (ICU patient);&#xD;
&#xD;
               -  -Need for postoperative ICU treatment or ventilation;&#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>Albert Dahan, MD, PhD, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leiden Medical University</name>
      <address>
        <city>Leiden</city>
        <state>Zuid Holland</state>
        <zip>2333ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <results_first_submitted>July 14, 2016</results_first_submitted>
  <results_first_submitted_qc>July 14, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 25, 2016</results_first_posted>
  <last_update_submitted>December 11, 2016</last_update_submitted>
  <last_update_submitted_qc>December 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>Albert Dahan</investigator_full_name>
    <investigator_title>Prof. Dr. A. Dahan</investigator_title>
  </responsible_party>
  <keyword>Neuromuscular block</keyword>
  <keyword>neuromuscular reversal</keyword>
  <keyword>postoperative conditions</keyword>
  <keyword>respiratory failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neostigmine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sugammadex</title>
          <description>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg&#xD;
Sugammadex</description>
        </group>
        <group group_id="P2">
          <title>Neostigmine</title>
          <description>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg&#xD;
Neostigmine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sugammadex</title>
          <description>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg&#xD;
Sugammadex</description>
        </group>
        <group group_id="B2">
          <title>Neostigmine</title>
          <description>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg&#xD;
Neostigmine</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="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years of age</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" lower_limit="27" upper_limit="72"/>
                    <measurement group_id="B2" value="55" lower_limit="19" upper_limit="94"/>
                    <measurement group_id="B3" value="55" lower_limit="19" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Lowest Saturation</title>
        <description>Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery</description>
        <time_frame>45 minutes post surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sugammadex</title>
            <description>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg&#xD;
Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Neostigmine</title>
            <description>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg&#xD;
Neostigmine</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Lowest Saturation</title>
          <description>Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery</description>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="96.1" upper_limit="97.4"/>
                    <measurement group_id="O2" value="93.3" lower_limit="91.9" upper_limit="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain</title>
        <description>using the 1-10 numeric rating scale</description>
        <time_frame>45 minutes post surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sugammadex</title>
            <description>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg&#xD;
Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Neostigmine</title>
            <description>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg&#xD;
Neostigmine</description>
          </group>
        </group_list>
        <measure>
          <title>Pain</title>
          <description>using the 1-10 numeric rating scale</description>
          <units>Numeric rating scale. 1(low)-10(maximum)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.3" upper_limit="3.7"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.4" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sedation</title>
        <description>using the Leiden observer alertness score (1 alert - 5 sedated)</description>
        <time_frame>45 minutes post surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sugammadex</title>
            <description>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg&#xD;
Sugammadex</description>
          </group>
          <group group_id="O2">
            <title>Neostigmine</title>
            <description>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg&#xD;
Neostigmine</description>
          </group>
        </group_list>
        <measure>
          <title>Sedation</title>
          <description>using the Leiden observer alertness score (1 alert - 5 sedated)</description>
          <units>sedation scale (1 alert - 5 sedated)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="1.2" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.4" lower_limit="1.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Sugammadex</title>
          <description>Subjects in this arm will be reversed with sugammadex 2-4 mg/kg&#xD;
Sugammadex</description>
        </group>
        <group group_id="E2">
          <title>Neostigmine</title>
          <description>subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg&#xD;
Neostigmine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </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>Prof Dr A. Dahan</name_or_title>
      <organization>LUMC</organization>
      <phone>+31 71 526 2301</phone>
      <email>a.dahan@lumc.nl</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/NCT02243943
org study id: NL34186.058.10
secondary id: NL34186.058.10
nct id: NCT02243943
lead sponsor: 
has dmc: No
Suboptimal reversal of neuromuscular blockage after surgery is possibly related to
      unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete
      reversal of neuromuscular block was not possible untill sugammadex was discovered. The
      investigators hyposthesise that reversal with sugammadex leads to favorable postoperative
      respiratory conditions and less pain compared to reversal with neostigmine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Lowest Saturation
time frame: 45 minutes post surgery
description: Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery
measure: Pain
time frame: 45 minutes post surgery
description: using the 1-10 numeric rating scale
measure: Sedation
time frame: 45 minutes post surgery
description: using the Leiden observer alertness score (1 alert - 5 sedated)
arm group label: Sugammadex
arm group type: Experimental
description: Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
arm group label: neostigmine
arm group type: Active Comparator
description: subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg
intervention type: Drug
intervention name: Sugammadex
arm group label: Sugammadex
other name: Bridion
intervention type: Drug
intervention name: Neostigmine
arm group label: neostigmine
other name: Prostigmin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Albert Dahan, MD, PhD, Professor
role: Principal Investigator
affiliation: Leiden Medical University
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: Albert Dahan
investigator title: Prof. Dr. A. Dahan
mesh term: Disease
mesh term: Neostigmine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 