<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/NCT03297021</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-1618</org_study_id>
    <nct_id>NCT03297021</nct_id>
  </id_info>
  <brief_title>Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting</brief_title>
  <official_title>Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to evaluate the effectiveness of three different regimens of prophylactic&#xD;
      ondansetron on the incidence and severity of post-operative nausea and vomiting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg&#xD;
      ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron&#xD;
      pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">April 5, 2019</completion_date>
  <primary_completion_date type="Actual">April 5, 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Nausea Scale</measure>
    <time_frame>average of 4 hours in PACU and POD1</time_frame>
    <description>Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Episodes of Vomiting in the PACU</measure>
    <time_frame>average of 4 hours</time_frame>
    <description>Number of participants with episodes of vomiting in the Post Anesthesia Care Unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Symptoms on POD 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Needed Rescue Anti-emetics</measure>
    <time_frame>average of 4 hours</time_frame>
    <description>Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Anesthesia Time</measure>
    <time_frame>intraoperative, up to 3.5 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Post-operative Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Ondansetron 4mg Pre-emergence</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ondansetron 8mg Pre-emergence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ondansetron Pre-Incision and Pre-emergence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron 4 MG</intervention_name>
    <description>dose as per arm selection</description>
    <arm_group_label>Ondansetron 4mg Pre-emergence</arm_group_label>
    <arm_group_label>Ondansetron Pre-Incision and Pre-emergence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron 8mg</intervention_name>
    <description>dose as per arm selection</description>
    <arm_group_label>Ondansetron 8mg Pre-emergence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I, II, III presenting for ambulatory surgery to be performed under general&#xD;
             anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with allergies or contraindications to study medications&#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>Daniel Katz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>June 30, 2020</results_first_submitted>
  <results_first_submitted_qc>July 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 20, 2020</results_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Daniel Katz</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>ambulatory surgery</keyword>
  <keyword>post-operative nausea and vomiting</keyword>
  <keyword>general anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03297021/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>165 patients assessed for eligibility 141 patients were randomized</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ondansetron 4mg Pre-emergence</title>
          <description>Ondansetron 4 MG Pre-emergence</description>
        </group>
        <group group_id="P2">
          <title>Ondansetron 8mg Pre-emergence</title>
          <description>Ondansetron 8mg Pre-emergence</description>
        </group>
        <group group_id="P3">
          <title>Ondansetron Pre-Incision and Pre-emergence</title>
          <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Incomplete/illegible data sheet</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing Post-Op Data</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ondansetron 4mg Pre-emergence</title>
          <description>Ondansetron 4 MG Pre-emergence</description>
        </group>
        <group group_id="B2">
          <title>Ondansetron 8mg Pre-emergence</title>
          <description>Ondansetron 8mg Pre-emergence</description>
        </group>
        <group group_id="B3">
          <title>Ondansetron Pre-Incision and Pre-emergence</title>
          <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="43"/>
            <count group_id="B4" value="128"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="33" upper_limit="51"/>
                    <measurement group_id="B2" value="39" lower_limit="30" upper_limit="51"/>
                    <measurement group_id="B3" value="48" lower_limit="31" upper_limit="57"/>
                    <measurement group_id="B4" value="40" lower_limit="30" upper_limit="57"/>
                  </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="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="14"/>
                  </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 group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA Class</title>
          <description>American Society of Anesthesiologist&#xD;
ASA 1: A normal healthy patient.&#xD;
ASA 2: A patient with a mild systemic disease.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B2" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B3" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B4" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index</description>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.0" lower_limit="21.0" upper_limit="27.0"/>
                    <measurement group_id="B2" value="25.0" lower_limit="22.0" upper_limit="29.2"/>
                    <measurement group_id="B3" value="24.0" lower_limit="21.0" upper_limit="28.6"/>
                    <measurement group_id="B4" value="24" lower_limit="21" upper_limit="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of PONV</title>
          <description>Post-operative nausea and vomiting</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="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Vertigo</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="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Motion Sickness</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="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Smoker</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="43"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="43"/>
                    <count group_id="B4" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Nausea Scale</title>
        <description>Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea</description>
        <time_frame>average of 4 hours in PACU and POD1</time_frame>
        <population>only those participants with nausea completed the nausea scale</population>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron 4mg Pre-emergence</title>
            <description>Ondansetron 4 MG Pre-emergence</description>
          </group>
          <group group_id="O2">
            <title>Ondansetron 8mg Pre-emergence</title>
            <description>Ondansetron 8mg Pre-emergence</description>
          </group>
          <group group_id="O3">
            <title>Ondansetron Pre-Incision and Pre-emergence</title>
            <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
          </group>
        </group_list>
        <measure>
          <title>Nausea Scale</title>
          <description>Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea</description>
          <population>only those participants with nausea completed the nausea scale</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PACU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="1.75" upper_limit="4.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.0" upper_limit="6.0"/>
                    <measurement group_id="O3" value="4.0" lower_limit="1.5" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="5.5"/>
                    <measurement group_id="O3" value="8.0" lower_limit="8.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Episodes of Vomiting in the PACU</title>
        <description>Number of participants with episodes of vomiting in the Post Anesthesia Care Unit</description>
        <time_frame>average of 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron 4mg Pre-emergence</title>
            <description>Ondansetron 4 MG Pre-emergence</description>
          </group>
          <group group_id="O2">
            <title>Ondansetron 8mg Pre-emergence</title>
            <description>Ondansetron 8mg Pre-emergence</description>
          </group>
          <group group_id="O3">
            <title>Ondansetron Pre-Incision and Pre-emergence</title>
            <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Episodes of Vomiting in the PACU</title>
          <description>Number of participants with episodes of vomiting in the Post Anesthesia Care Unit</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Symptoms on POD 1</title>
        <description>Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron 4mg Pre-emergence</title>
            <description>Ondansetron 4 MG Pre-emergence</description>
          </group>
          <group group_id="O2">
            <title>Ondansetron 8mg Pre-emergence</title>
            <description>Ondansetron 8mg Pre-emergence</description>
          </group>
          <group group_id="O3">
            <title>Ondansetron Pre-Incision and Pre-emergence</title>
            <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Symptoms on POD 1</title>
          <description>Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Needed Rescue Anti-emetics</title>
        <description>Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU</description>
        <time_frame>average of 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron 4mg Pre-emergence</title>
            <description>Ondansetron 4 MG Pre-emergence</description>
          </group>
          <group group_id="O2">
            <title>Ondansetron 8mg Pre-emergence</title>
            <description>Ondansetron 8mg Pre-emergence</description>
          </group>
          <group group_id="O3">
            <title>Ondansetron Pre-Incision and Pre-emergence</title>
            <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Needed Rescue Anti-emetics</title>
          <description>Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Anesthesia Time</title>
        <time_frame>intraoperative, up to 3.5 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ondansetron 4mg Pre-emergence</title>
            <description>Ondansetron 4 MG Pre-emergence</description>
          </group>
          <group group_id="O2">
            <title>Ondansetron 8mg Pre-emergence</title>
            <description>Ondansetron 8mg Pre-emergence</description>
          </group>
          <group group_id="O3">
            <title>Ondansetron Pre-Incision and Pre-emergence</title>
            <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</description>
          </group>
        </group_list>
        <measure>
          <title>Total Anesthesia Time</title>
          <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="43"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.0" lower_limit="93.0" upper_limit="178.0"/>
                    <measurement group_id="O2" value="128.5" lower_limit="86.5" upper_limit="186.25"/>
                    <measurement group_id="O3" value="118.0" lower_limit="93.0" upper_limit="172.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ondansetron 4mg Pre-emergence</title>
          <description>Ondansetron 4 MG Pre-emergence</description>
        </group>
        <group group_id="E2">
          <title>Ondansetron 8mg Pre-emergence</title>
          <description>Ondansetron 8mg Pre-emergence</description>
        </group>
        <group group_id="E3">
          <title>Ondansetron Pre-Incision and Pre-emergence</title>
          <description>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence</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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </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. Daniel Katz</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>212-241-7475</phone>
      <email>Daniel.Katz@mountsinai.org</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/NCT03297021
org study id: GCO 17-1618
nct id: NCT03297021
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The aim is to evaluate the effectiveness of three different regimens of prophylactic
      ondansetron on the incidence and severity of post-operative nausea and vomiting.
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg
      ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron
      pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.
measure: Nausea Scale
time frame: average of 4 hours in PACU and POD1
description: Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
measure: Number of Participants With Episodes of Vomiting in the PACU
time frame: average of 4 hours
description: Number of participants with episodes of vomiting in the Post Anesthesia Care Unit
measure: Number of Participants With Symptoms on POD 1
time frame: Day 1
description: Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
measure: Number of Participants Who Needed Rescue Anti-emetics
time frame: average of 4 hours
description: Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU
measure: Total Anesthesia Time
time frame: intraoperative, up to 3.5 hours
arm group label: Ondansetron 4mg Pre-emergence
arm group type: Placebo Comparator
arm group label: Ondansetron 8mg Pre-emergence
arm group type: Experimental
arm group label: Ondansetron Pre-Incision and Pre-emergence
arm group type: Experimental
description: 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
intervention type: Drug
intervention name: Ondansetron 4 MG
description: dose as per arm selection
arm group label: Ondansetron 4mg Pre-emergence
arm group label: Ondansetron Pre-Incision and Pre-emergence
intervention type: Drug
intervention name: Ondansetron 8mg
description: dose as per arm selection
arm group label: Ondansetron 8mg Pre-emergence
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Katz, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Daniel Katz
investigator title: Assistant Professor
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Ondansetron
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 