<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/NCT02202239</url>
  </required_header>
  <id_info>
    <org_study_id>20140723</org_study_id>
    <nct_id>NCT02202239</nct_id>
  </id_info>
  <brief_title>Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhujiang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the effect of induction and maintenance of anesthesia with etomidate on&#xD;
      hemodynamics and oxidative stress in diabetic patients.&#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">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 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>Mean arterial pressure</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>Mean arterial pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central venous pressure</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>Central venous pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>Heart rate will be recorded 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>Respiratory rate will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>Oxygen saturation will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>Blood glucose will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5).&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>Insulin will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5).&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Super oxide dismutase</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before super oxide dismutase was measured.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glutathione</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before glutathione was measured.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Xanthine oxidase</measure>
    <time_frame>from 10 minutes before induction to 1 h after the surgery</time_frame>
    <description>2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before xanthine oxidase dismutase was measured.&#xD;
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hemodynamics</condition>
  <condition>Oxidative Stress</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etomidate was used in both induction and maintenance of anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group P</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Propofol was used in both induction and maintenance of anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midazolam</intervention_name>
    <description>Before induction, midazolam 0.05mg/kg will be injected intravenously.</description>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group P</arm_group_label>
    <other_name>Li Yue Xi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Penehyclidine Hydrochloride Injection</intervention_name>
    <description>Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.</description>
    <arm_group_label>Group E</arm_group_label>
    <other_name>Chang Tuo Ning</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etomidate</intervention_name>
    <description>Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.</description>
    <arm_group_label>Group E</arm_group_label>
    <other_name>Fu Er Li</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.</description>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.</description>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisatracurium Besilate</intervention_name>
    <description>Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.&#xD;
During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation.</description>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Remifentanil will be injected continuously during maintenance of anesthesia.</description>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.</description>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 65 years;&#xD;
&#xD;
          -  Diabetic patients preparing for elective surgery;&#xD;
&#xD;
          -  Body mass index is between 16 and 30 kg/m2;&#xD;
&#xD;
          -  Blood glucose is under 8.3 mmol/kg by oral antidiabetic agents or diet control;&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ;&#xD;
&#xD;
          -  Expected operation duration is between 2 and 8 h;&#xD;
&#xD;
          -  Signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiac, cerebral, liver, kidney, lung, endocrine disease or infectious&#xD;
             disease;&#xD;
&#xD;
          -  Chemotherapy or immunotherapy before the surgery;&#xD;
&#xD;
          -  Allergy to trial drug or other contraindication;&#xD;
&#xD;
          -  Expected or history of difficult airway;&#xD;
&#xD;
          -  Suspected abuse of narcotic analgesia;&#xD;
&#xD;
          -  Diseases of neuromuscular system;&#xD;
&#xD;
          -  Mentally unstable or has a mental illness;&#xD;
&#xD;
          -  Trend of malignant hyperthermia;&#xD;
&#xD;
          -  Pregnant or breast-feeding women;&#xD;
&#xD;
          -  Attendance of other trial past 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 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>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Etomidate</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Cisatracurium</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/NCT02202239
org study id: 20140723
nct id: NCT02202239
lead sponsor: 
has dmc: Yes
To explore the effect of induction and maintenance of anesthesia with etomidate on
      hemodynamics and oxidative stress in diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean arterial pressure
time frame: from 10 minutes before induction to 1 h after the surgery
description: Mean arterial pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Central venous pressure
time frame: from 10 minutes before induction to 1 h after the surgery
description: Central venous pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Heart rate
time frame: from 10 minutes before induction to 1 h after the surgery
description: Heart rate will be recorded 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Respiratory rate
time frame: from 10 minutes before induction to 1 h after the surgery
description: Respiratory rate will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Oxygen saturation
time frame: from 10 minutes before induction to 1 h after the surgery
description: Oxygen saturation will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Blood glucose
time frame: from 10 minutes before induction to 1 h after the surgery
description: Blood glucose will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5).
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Insulin
time frame: from 10 minutes before induction to 1 h after the surgery
description: Insulin will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5).
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Super oxide dismutase
time frame: from 10 minutes before induction to 1 h after the surgery
description: 2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before super oxide dismutase was measured.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Glutathione
time frame: from 10 minutes before induction to 1 h after the surgery
description: 2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before glutathione was measured.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
measure: Xanthine oxidase
time frame: from 10 minutes before induction to 1 h after the surgery
description: 2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before xanthine oxidase dismutase was measured.
Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
arm group label: Group E
arm group type: Experimental
description: Etomidate was used in both induction and maintenance of anesthesia.
arm group label: Group P
arm group type: Active Comparator
description: Propofol was used in both induction and maintenance of anesthesia.
intervention type: Drug
intervention name: midazolam
description: Before induction, midazolam 0.05mg/kg will be injected intravenously.
arm group label: Group E
arm group label: Group P
other name: Li Yue Xi
intervention type: Drug
intervention name: Penehyclidine Hydrochloride Injection
description: Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.
arm group label: Group E
other name: Chang Tuo Ning
intervention type: Drug
intervention name: Etomidate
description: Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.
arm group label: Group E
other name: Fu Er Li
intervention type: Drug
intervention name: Propofol
description: Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.
arm group label: Group P
intervention type: Drug
intervention name: Fentanyl
description: During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.
arm group label: Group E
arm group label: Group P
intervention type: Drug
intervention name: Cisatracurium Besilate
description: Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.
During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation.
arm group label: Group E
arm group label: Group P
intervention type: Drug
intervention name: Remifentanil
description: Remifentanil will be injected continuously during maintenance of anesthesia.
arm group label: Group E
arm group label: Group P
intervention type: Drug
intervention name: Sevoflurane
description: Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.
arm group label: Group E
arm group label: Group P
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Remifentanil
mesh term: Propofol
mesh term: Etomidate
mesh term: Sevoflurane
mesh term: Cisatracurium