<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/NCT01729897</url>
  </required_header>
  <id_info>
    <org_study_id>ChiCTR-TRC-20121001</org_study_id>
    <nct_id>NCT01729897</nct_id>
  </id_info>
  <brief_title>Etomidate Emulsion for Sedation in Patients Scheduled for Upper Gastrointestinal (GI) Endoscopy</brief_title>
  <official_title>A Multicenter Open-label Randomized Controlled Clinical Trial of Etomidate Emulsion for Sedation in Patients Scheduled for Upper GI Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Nhwa Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Nhwa Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to explore and compare the efficacy and safety of etomidate and&#xD;
      propofol with or without analgesic for painless gastroscopy, and to provide more reliant&#xD;
      support for implementation and promotion of comfort care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To widely implement painless gastroscopy is required by diagnose and treatment with&#xD;
      gastroscopy due to the large number and significant suffering of the patients. Also,&#xD;
      development and exploration of anesthesiology will be bound to prompt the development and&#xD;
      exploration of painless gastroscopy. However, the anesthesia risk of painless gastroscopy are&#xD;
      usually higher than that of general anesthesia performed in operating room due to the&#xD;
      condition, monitoring and equipments as well as the staffing for its implementation. Thus,&#xD;
      the finding of a safe and convenient approach for general anesthesia will have a profound&#xD;
      impact on a full promotion and implementation of comfortable care.&#xD;
&#xD;
      Etomidate, with the main advantage of little effect on circulatory and respiratory systems,&#xD;
      and the features of rapid onset and metabolism, may be helpful to guarantee the safety of&#xD;
      painless diagnosis and treatment, thus appropriate for the procedure with short duration of&#xD;
      anesthesia. However, there is controversy regarding whether analgesic should be used in&#xD;
      combination, as well as how to given the combined regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the minimum blood pressure</measure>
    <time_frame>participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the proportion of hypotension</measure>
    <time_frame>participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the minimum oxygen saturation of blood</measure>
    <time_frame>participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time interval</measure>
    <time_frame>from the last administration of etomidate to when the patient leave the hospital</time_frame>
    <description>the time interval that from the last administration of etomidate to when the patient leave the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of the side effects</measure>
    <time_frame>participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours</time_frame>
    <description>the side effects include dizziness，nausea，vomit，myoclonia，injection pain，and the awareness during operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the cost of the experiment drug</measure>
    <time_frame>the money that the participants spend from the beginning of the surgery to leaving hospital，an expected average of 4 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Other adverse events except above</measure>
    <time_frame>participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>the changes of the primary clinical symptoms</measure>
    <time_frame>participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>the abnormal laboratory examinations</measure>
    <time_frame>participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">328</enrollment>
  <condition>Complication of Gastrostomy</condition>
  <arm_group>
    <arm_group_label>Etomidate &amp; Fentanyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 min before procedure: fentanyl 1 μg/kg (0.02 ml/kg), intravenous injection&#xD;
After injection of fentanyl, etomidate was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.&#xD;
Additional dose of etomidate would be administrated separately when duration of procedure was prolonged.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol &amp; Fentanyl</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>4 min before procedure: fentanyl 1 g/kg (0.02 ml/kg), intravenous injection&#xD;
After injection of fentanyl, propofol was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.&#xD;
Additional dose of propofol would be administrated separately when duration of procedure was prolonged.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etomidate</intervention_name>
    <arm_group_label>Etomidate &amp; Fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <arm_group_label>Etomidate &amp; Fentanyl</arm_group_label>
    <arm_group_label>Propofol &amp; Fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <arm_group_label>Propofol &amp; Fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for painless gastroscopy&#xD;
&#xD;
          -  18-80 year old&#xD;
&#xD;
          -  18 H2 ≤ weight ≤ 35 H2 (H indicates height)&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status class 1-3&#xD;
&#xD;
          -  The duration of surgery is ≤ 60 min ( duration of surgery was defined as the interval&#xD;
             time from insert to withdraw of catheter)&#xD;
&#xD;
          -  Without liver, kidney and heart disease history&#xD;
&#xD;
          -  No previous history of abnormal recovery of anesthesia in surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whom do not wish to perform painless gastroscopy or participate in the study&#xD;
&#xD;
          -  Patients with medical history of severe heart, lung, liver, kidney or metabolic&#xD;
             disease&#xD;
&#xD;
          -  Patients with abnormal ECG presented as heart rate 50 &lt; beat/min&#xD;
&#xD;
          -  Patients who suffered from acute inflammation of respiratory tract within the past 2&#xD;
             weeks and did not be cured of it before participating in the study&#xD;
&#xD;
          -  Hypertension patient with preoperative blood pressure &gt; 180/90 mmHg; hypotension&#xD;
             patients with preoperative blood pressure &lt; 90/60 mmHg;&#xD;
&#xD;
          -  Patients with neuromuscular disease, mental disorders&#xD;
&#xD;
          -  Hemoglobin is less than 90 g/L&#xD;
&#xD;
          -  Patients with suspected abuse of Anesthesia and Analgesia&#xD;
&#xD;
          -  Patients who were predicted to have or had previous difficult airway ( difficult&#xD;
             airway is defined as the clinical situation in which a conventionally trained&#xD;
             anesthesiologist experiences three failures of intubation)&#xD;
&#xD;
          -  Patients with known emulsion or opioid allergy&#xD;
&#xD;
          -  Patients who will be noncompliant or unable to communicate&#xD;
&#xD;
          -  Patients who received long-term treatment with hormone or had history of&#xD;
             adrenocortical suppression&#xD;
&#xD;
          -  Patients received coadministration of other sedative, analgesic ( including injection,&#xD;
             oral or usage of relevant Chinese patent medicine) before, during or 15 min after the&#xD;
             procedure&#xD;
&#xD;
          -  Patients who appeared nausea and vomit, dizziness&#xD;
&#xD;
          -  Patients with sever diabetes mellitus, hyperkaliemia or significant electrolyte&#xD;
             disturbances&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 10, 2013</last_update_submitted>
  <last_update_submitted_qc>May 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastroscopy</keyword>
  <keyword>sedation</keyword>
  <keyword>etomidate</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Etomidate</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>October 14, 2013</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>November 11, 2013</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>February 25, 2014</submitted>
    <returned>April 4, 2014</returned>
  </pending_results>
  <!-- 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/NCT01729897
org study id: ChiCTR-TRC-20121001
nct id: NCT01729897
lead sponsor: 
has dmc: Yes
The study is designed to explore and compare the efficacy and safety of etomidate and
      propofol with or without analgesic for painless gastroscopy, and to provide more reliant
      support for implementation and promotion of comfort care.
To widely implement painless gastroscopy is required by diagnose and treatment with
      gastroscopy due to the large number and significant suffering of the patients. Also,
      development and exploration of anesthesiology will be bound to prompt the development and
      exploration of painless gastroscopy. However, the anesthesia risk of painless gastroscopy are
      usually higher than that of general anesthesia performed in operating room due to the
      condition, monitoring and equipments as well as the staffing for its implementation. Thus,
      the finding of a safe and convenient approach for general anesthesia will have a profound
      impact on a full promotion and implementation of comfortable care.

      Etomidate, with the main advantage of little effect on circulatory and respiratory systems,
      and the features of rapid onset and metabolism, may be helpful to guarantee the safety of
      painless diagnosis and treatment, thus appropriate for the procedure with short duration of
      anesthesia. However, there is controversy regarding whether analgesic should be used in
      combination, as well as how to given the combined regimen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the minimum blood pressure
time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
measure: the proportion of hypotension
time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
measure: the minimum oxygen saturation of blood
time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
measure: Time interval
time frame: from the last administration of etomidate to when the patient leave the hospital
description: the time interval that from the last administration of etomidate to when the patient leave the hospital
measure: Incidence rate of the side effects
time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
description: the side effects include dizziness，nausea，vomit，myoclonia，injection pain，and the awareness during operation
measure: the cost of the experiment drug
time frame: the money that the participants spend from the beginning of the surgery to leaving hospital，an expected average of 4 hours
measure: Other adverse events except above
time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
measure: the changes of the primary clinical symptoms
time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
measure: the abnormal laboratory examinations
time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
arm group label: Etomidate & Fentanyl
arm group type: Experimental
description: 4 min before procedure: fentanyl 1 μg/kg (0.02 ml/kg), intravenous injection
After injection of fentanyl, etomidate was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.
Additional dose of etomidate would be administrated separately when duration of procedure was prolonged.
arm group label: Propofol & Fentanyl
arm group type: Placebo Comparator
description: 4 min before procedure: fentanyl 1 g/kg (0.02 ml/kg), intravenous injection
After injection of fentanyl, propofol was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.
Additional dose of propofol would be administrated separately when duration of procedure was prolonged.
intervention type: Drug
intervention name: Etomidate
arm group label: Etomidate & Fentanyl
intervention type: Drug
intervention name: Fentanyl
arm group label: Etomidate & Fentanyl
arm group label: Propofol & Fentanyl
intervention type: Drug
intervention name: Propofol
arm group label: Propofol & Fentanyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Fentanyl
mesh term: Propofol
mesh term: Etomidate
submitted: October 14, 2013
submission canceled: Unknown
submitted: November 11, 2013
submission canceled: Unknown
submitted: February 25, 2014
returned: April 4, 2014