<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/NCT03820388</url>
  </required_header>
  <id_info>
    <org_study_id>909765</org_study_id>
    <nct_id>NCT03820388</nct_id>
  </id_info>
  <brief_title>Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia</brief_title>
  <official_title>Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of&#xD;
      anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of&#xD;
      anesthesia. The specific aims are testing patient reactions during induction, and in the&#xD;
      post-anesthesia care unit (PACU).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">July 13, 2018</completion_date>
  <primary_completion_date type="Actual">July 13, 2018</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>
    <intervention_model_description>Patients in 3 cohorts will be administered 30 second bolus by manual hand push</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>10 minutes after induction (intraoperative)</time_frame>
    <description>Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>10 minutes after induction (intraoperative)</time_frame>
    <description>Heart Rate changes during induction (Beats Per min)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain at Injection Site</measure>
    <time_frame>intraoperative</time_frame>
    <description>Pain on injection will be measured using 4 graded scale; 0 = no pain, 1 = verbal complaint of pain, 2 = withdrawal of arm, 3 = both verbal complaint and withdrawal of arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myoclonic Movements</measure>
    <time_frame>intraoperative</time_frame>
    <description>The incidence and degree of myoclonic movements also recorded as follows: 0 = no myoclonic movements, 1 = minor myoclonic movements, 2 = moderate myoclonic movements, 3 = major myoclonic movements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Nausea and Vomiting</measure>
    <time_frame>24 hours post-operation</time_frame>
    <description>Presence of post-operative nausea or vomiting (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation Depth</measure>
    <time_frame>30 minutes post-induction</time_frame>
    <description>Sedation depth using bispectral index (BIS). BIS scores range from 0-100. A value of 0 indicates no EEG activity, 40-60 indicates an appropriate level of general anesthesia, and 90-100 is typical of a state of wakefulness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eyelash Reflex Disappear Time</measure>
    <time_frame>Post induction, up to 1 hour</time_frame>
    <description>Time to disappearance of eyelash reflex after induction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation Time</measure>
    <time_frame>Up to 2 hours</time_frame>
    <description>Duration of orotracheal intubation.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Propofol Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Propofol 2 mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etomidate Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etomidate 0.3 mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol plus Etomidate Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol 2mg/kg</intervention_name>
    <description>2 mg/kg</description>
    <arm_group_label>Propofol Group</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etomidate 0.3 mg/kg</intervention_name>
    <description>0.3 mg/kg</description>
    <arm_group_label>Etomidate Group</arm_group_label>
    <other_name>Amidate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol 1 mg/kg</intervention_name>
    <description>1 mg/kg Propofol</description>
    <arm_group_label>Propofol plus Etomidate Group</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etomidate 0.15 mg/kg</intervention_name>
    <description>0.15 mg/kg Etomidate</description>
    <arm_group_label>Propofol plus Etomidate Group</arm_group_label>
    <other_name>Amidate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective non-cardiac surgery&#xD;
&#xD;
          -  ASA physical status of 2 or 3&#xD;
&#xD;
          -  Age equal to or greater than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to provide consent&#xD;
&#xD;
          -  Age less than 18 years old&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Difficult airway&#xD;
&#xD;
          -  Morbid Obesity&#xD;
&#xD;
          -  Preoperative sedation use&#xD;
&#xD;
          -  Severe Cardiac, pulmonary and liver disease&#xD;
&#xD;
          -  Hypotension and shock&#xD;
&#xD;
          -  Emergency surgeries&#xD;
&#xD;
          -  Allergy to propofol or etomidate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <results_first_submitted>December 2, 2020</results_first_submitted>
  <results_first_submitted_qc>February 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2021</results_first_posted>
  <last_update_submitted>February 4, 2021</last_update_submitted>
  <last_update_submitted_qc>February 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Etomidate</keyword>
  <keyword>Propofol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Etomidate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03820388/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03820388/SAP_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03820388/ICF_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Propofol Group</title>
          <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
        </group>
        <group group_id="P2">
          <title>Etomidate Group</title>
          <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
        </group>
        <group group_id="P3">
          <title>Propofol Plus Etomidate Group</title>
          <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Propofol Group</title>
          <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
        </group>
        <group group_id="B2">
          <title>Etomidate Group</title>
          <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
        </group>
        <group group_id="B3">
          <title>Propofol Plus Etomidate Group</title>
          <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</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="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="75"/>
          </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="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.2" spread="8.5"/>
                    <measurement group_id="B2" value="62.5" spread="14.7"/>
                    <measurement group_id="B3" value="61.4" spread="11.6"/>
                    <measurement group_id="B4" value="61.7" spread="11.6"/>
                  </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="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Pressure</title>
        <description>Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.</description>
        <time_frame>10 minutes after induction (intraoperative)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure</title>
          <description>Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" spread="16"/>
                    <measurement group_id="O2" value="122" spread="23"/>
                    <measurement group_id="O3" value="117.88" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate</title>
        <description>Heart Rate changes during induction (Beats Per min)</description>
        <time_frame>10 minutes after induction (intraoperative)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate</title>
          <description>Heart Rate changes during induction (Beats Per min)</description>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77" spread="17"/>
                    <measurement group_id="O2" value="74" spread="12"/>
                    <measurement group_id="O3" value="74" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain at Injection Site</title>
        <description>Pain on injection will be measured using 4 graded scale; 0 = no pain, 1 = verbal complaint of pain, 2 = withdrawal of arm, 3 = both verbal complaint and withdrawal of arm.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Pain at Injection Site</title>
          <description>Pain on injection will be measured using 4 graded scale; 0 = no pain, 1 = verbal complaint of pain, 2 = withdrawal of arm, 3 = both verbal complaint and withdrawal of arm.</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="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Myoclonic Movements</title>
        <description>The incidence and degree of myoclonic movements also recorded as follows: 0 = no myoclonic movements, 1 = minor myoclonic movements, 2 = moderate myoclonic movements, 3 = major myoclonic movements.</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Myoclonic Movements</title>
          <description>The incidence and degree of myoclonic movements also recorded as follows: 0 = no myoclonic movements, 1 = minor myoclonic movements, 2 = moderate myoclonic movements, 3 = major myoclonic movements.</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="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Nausea and Vomiting</title>
        <description>Presence of post-operative nausea or vomiting (yes/no).</description>
        <time_frame>24 hours post-operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Nausea and Vomiting</title>
          <description>Presence of post-operative nausea or vomiting (yes/no).</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="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <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>Sedation Depth</title>
        <description>Sedation depth using bispectral index (BIS). BIS scores range from 0-100. A value of 0 indicates no EEG activity, 40-60 indicates an appropriate level of general anesthesia, and 90-100 is typical of a state of wakefulness.</description>
        <time_frame>30 minutes post-induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Sedation Depth</title>
          <description>Sedation depth using bispectral index (BIS). BIS scores range from 0-100. A value of 0 indicates no EEG activity, 40-60 indicates an appropriate level of general anesthesia, and 90-100 is typical of a state of wakefulness.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" spread="8.4"/>
                    <measurement group_id="O2" value="38" spread="11"/>
                    <measurement group_id="O3" value="38" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eyelash Reflex Disappear Time</title>
        <description>Time to disappearance of eyelash reflex after induction.</description>
        <time_frame>Post induction, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Eyelash Reflex Disappear Time</title>
          <description>Time to disappearance of eyelash reflex after induction.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" spread="8.3"/>
                    <measurement group_id="O2" value="34.5" spread="7.5"/>
                    <measurement group_id="O3" value="32.4" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intubation Time</title>
        <description>Duration of orotracheal intubation.</description>
        <time_frame>Up to 2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
          </group>
          <group group_id="O2">
            <title>Etomidate Group</title>
            <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Propofol Plus Etomidate Group</title>
            <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</description>
          </group>
        </group_list>
        <measure>
          <title>Intubation Time</title>
          <description>Duration of orotracheal intubation.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" spread="9.6"/>
                    <measurement group_id="O2" value="95" spread="8.9"/>
                    <measurement group_id="O3" value="93" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>duration in-hospital up to 24 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Propofol Group</title>
          <description>Propofol 2 mg/kg&#xD;
Propofol 2mg/kg: 2 mg/kg</description>
        </group>
        <group group_id="E2">
          <title>Etomidate Group</title>
          <description>Etomidate 0.3 mg/kg&#xD;
Etomidate 0.3 mg/kg: 0.3 mg/kg</description>
        </group>
        <group group_id="E3">
          <title>Propofol Plus Etomidate Group</title>
          <description>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg&#xD;
Propofol 1 mg/kg: 1 mg/kg Propofol&#xD;
Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </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. Hong Liu</name_or_title>
      <organization>University of California Davis</organization>
      <phone>916-734-5031</phone>
      <email>hualiu@ucdavis.edu</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/NCT03820388
org study id: 909765
nct id: NCT03820388
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of
      anesthesia.
Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of
      anesthesia. The specific aims are testing patient reactions during induction, and in the
      post-anesthesia care unit (PACU).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients in 3 cohorts will be administered 30 second bolus by manual hand push
primary purpose: Supportive Care
masking: Single (Participant)
measure: Blood Pressure
time frame: 10 minutes after induction (intraoperative)
description: Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.
measure: Heart Rate
time frame: 10 minutes after induction (intraoperative)
description: Heart Rate changes during induction (Beats Per min)
measure: Pain at Injection Site
time frame: intraoperative
description: Pain on injection will be measured using 4 graded scale; 0 = no pain, 1 = verbal complaint of pain, 2 = withdrawal of arm, 3 = both verbal complaint and withdrawal of arm.
measure: Myoclonic Movements
time frame: intraoperative
description: The incidence and degree of myoclonic movements also recorded as follows: 0 = no myoclonic movements, 1 = minor myoclonic movements, 2 = moderate myoclonic movements, 3 = major myoclonic movements.
measure: Post-operative Nausea and Vomiting
time frame: 24 hours post-operation
description: Presence of post-operative nausea or vomiting (yes/no).
measure: Sedation Depth
time frame: 30 minutes post-induction
description: Sedation depth using bispectral index (BIS). BIS scores range from 0-100. A value of 0 indicates no EEG activity, 40-60 indicates an appropriate level of general anesthesia, and 90-100 is typical of a state of wakefulness.
measure: Eyelash Reflex Disappear Time
time frame: Post induction, up to 1 hour
description: Time to disappearance of eyelash reflex after induction.
measure: Intubation Time
time frame: Up to 2 hours
description: Duration of orotracheal intubation.
arm group label: Propofol Group
arm group type: Experimental
description: Propofol 2 mg/kg
arm group label: Etomidate Group
arm group type: Experimental
description: Etomidate 0.3 mg/kg
arm group label: Propofol plus Etomidate Group
arm group type: Experimental
description: Propofol 1 mg/kg plus Etomidate 0.15 mg/kg
intervention type: Drug
intervention name: Propofol 2mg/kg
description: 2 mg/kg
arm group label: Propofol Group
other name: Diprivan
intervention type: Drug
intervention name: Etomidate 0.3 mg/kg
description: 0.3 mg/kg
arm group label: Etomidate Group
other name: Amidate
intervention type: Drug
intervention name: Propofol 1 mg/kg
description: 1 mg/kg Propofol
arm group label: Propofol plus Etomidate Group
other name: Diprivan
intervention type: Drug
intervention name: Etomidate 0.15 mg/kg
description: 0.15 mg/kg Etomidate
arm group label: Propofol plus Etomidate Group
other name: Amidate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Liu, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Propofol
mesh term: Etomidate
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 