<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/NCT02208596</url>
  </required_header>
  <id_info>
    <org_study_id>20140729</org_study_id>
    <nct_id>NCT02208596</nct_id>
  </id_info>
  <brief_title>The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Affiliated Hospital of Zhengzhou University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the feasibility of different doses of etomidate admixed with propofol in induced&#xD;
      abortion: a randomized, double blind controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</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>Heart rate</measure>
    <time_frame>From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection</time_frame>
    <description>Heart rate will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection</time_frame>
    <description>Blood pressure will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse oxygen saturation</measure>
    <time_frame>From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection</time_frame>
    <description>Pulse oxygen saturation will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of anesthesia</measure>
    <time_frame>from baseline to discharge from the hospital, expected to no more than 1 hour</time_frame>
    <description>The following point-in-time will be recorded to calculated the period from the injection of propofol or mixture of propofol and etomidate: disappearance of eyelash reflex, injection of supplementary propofol or mixture of propofol and etomidate, awaking, obeying commands, discharge. Anesthesia time was defined as the period from disappearance of eyelash reflex to awaking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose of propofol or mixture of propofol and etomidate</measure>
    <time_frame>from the injection of propofol or mixture of propofol and etomidate to the last supplement of hypnotic agents, expected to be no more than 5 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of specific medications</measure>
    <time_frame>from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aldrete score</measure>
    <time_frame>10 min after the opration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal rating scales of uterine contraction</measure>
    <time_frame>from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour</time_frame>
    <description>Verbal rating scales of uterine contraction should be recorded at 5 min, 15 min after the operation and before discharge from the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction degree of the patient, the surgeon and the anesthetist</measure>
    <time_frame>10 min before discharge from the hospital</time_frame>
    <description>Satisfaction degree will be rated as excellent, good and poor based on a scale of 1 to 10. Excellent is 8 to 10, good is 5 to 7 and poor is 1 to 4.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Induced Abortion</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In group C, propofol (1%) will be injected continuously until the eyelash reflex disappears. During the operation, supplementary propofol will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pentazocine</intervention_name>
    <description>Every patient enrolled in the study will be given 15 mg pentazocine before induction.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etomidate</intervention_name>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 20 and 35 years&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ&#xD;
&#xD;
          -  Singleton pregnancy and the gestational period is 6 to 8 weeks&#xD;
&#xD;
          -  Expected operation duration is within 60 minutes&#xD;
&#xD;
          -  The body weight should be within 15% around the standard weight&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious cardiac, cerebral, liver, kidney, lung, endocrine disease&#xD;
&#xD;
          -  Upper respiratory infections within 4 weeks&#xD;
&#xD;
          -  Long use of hormone or history of adrenal suppression&#xD;
&#xD;
          -  History of use of glucocorticoids, aprotinin or immunosuppressant&#xD;
&#xD;
          -  Manifestation of immunodeficiency&#xD;
&#xD;
          -  History of use of sedatives or opiates&#xD;
&#xD;
          -  Needs of Neuromuscular blocker (except intubation)&#xD;
&#xD;
          -  Allergy to trial drug or other contraindication&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Attended other trial past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 3, 2014</last_update_submitted>
  <last_update_submitted_qc>August 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pentazocine</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Etomidate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02208596
org study id: 20140729
nct id: NCT02208596
lead sponsor: 
has dmc: Yes
To explore the feasibility of different doses of etomidate admixed with propofol in induced
      abortion: a randomized, double blind controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Heart rate
time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
description: Heart rate will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
measure: Blood pressure
time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
description: Blood pressure will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
measure: Pulse oxygen saturation
time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
description: Pulse oxygen saturation will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
measure: Efficacy of anesthesia
time frame: from baseline to discharge from the hospital, expected to no more than 1 hour
description: The following point-in-time will be recorded to calculated the period from the injection of propofol or mixture of propofol and etomidate: disappearance of eyelash reflex, injection of supplementary propofol or mixture of propofol and etomidate, awaking, obeying commands, discharge. Anesthesia time was defined as the period from disappearance of eyelash reflex to awaking.
measure: Dose of propofol or mixture of propofol and etomidate
time frame: from the injection of propofol or mixture of propofol and etomidate to the last supplement of hypnotic agents, expected to be no more than 5 min
measure: Use of specific medications
time frame: from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour
measure: Aldrete score
time frame: 10 min after the opration
measure: Verbal rating scales of uterine contraction
time frame: from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour
description: Verbal rating scales of uterine contraction should be recorded at 5 min, 15 min after the operation and before discharge from the hospital
measure: Satisfaction degree of the patient, the surgeon and the anesthetist
time frame: 10 min before discharge from the hospital
description: Satisfaction degree will be rated as excellent, good and poor based on a scale of 1 to 10. Excellent is 8 to 10, good is 5 to 7 and poor is 1 to 4.
arm group label: Group A
arm group type: Experimental
description: In group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
arm group label: Group B
arm group type: Experimental
description: In group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
arm group label: Group C
arm group type: Experimental
description: In group C, propofol (1%) will be injected continuously until the eyelash reflex disappears. During the operation, supplementary propofol will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
intervention type: Drug
intervention name: pentazocine
description: Every patient enrolled in the study will be given 15 mg pentazocine before induction.
arm group label: Group A
arm group label: Group B
arm group label: Group C
intervention type: Drug
intervention name: propofol
arm group label: Group A
arm group label: Group B
arm group label: Group C
intervention type: Drug
intervention name: Etomidate
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Pentazocine
mesh term: Propofol
mesh term: Etomidate