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Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

Sponsor
Henan Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05223907
Collaborator
(none)
1,080
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
54
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was designed to use etomidate combined with sevoflurane intravenously to maintain anesthesia process under the monitoring of BIS. Propofol was used as the controls. Blood pressure and heart rate were recorded during operation. The VAS pain score was observed after surgery.To investigate whether this program can better maintain intraoperative hemodynamic stability, improve the quality of recovery, and reduce the incidence of postoperative adverse reactions.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1080 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Maintenance of Etomidate Combined With Sevoflurane in General Anesthesia: a Multi-center Randomized Controlled Study
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group Etomidate

Etomidate will be used for general anesthesia

Drug: Etomidate
Etomidate will be used for general anesthesia
Other Names:
  • Etomidate Injectable Emulsion
  • Yituomizhi, H20020511, WS-400(X-338)-2002-2015Z,YT211101

    		•
    Experimental: Group Propofol

    Propofol will be used for general anesthesia

    Drug: Propofol
    Propofol will be used for general anesthesia
    Other Names:
  • Diprivan, JX20060102，H20080473，RW981

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of intraoperative hypertension and hypotension [From the beginning to the end of surgery]

      Investigators will record the rate of hypertension and hypotension of participants during intraoperative period

    2. Ricker sedation-agitation score after surgery [1 day (The period during patients wake up after surgery and general anesthesia in the recovery room.)]

      Investigators will record the Ricker sedation-agitation score of participants during recovery period after general anestesia

    Secondary Outcome Measures

    1. Postoperative pain scores measured by VAS score. [One-three days after surgery.]

      Postoperative pain scores of participants will be assessed by using VAS score (0= no pain, 10= worse pain imaginable)

    2. The incidence of PONV [One-three days after surgery.]

      The incidence of postoperative nausea and vomiting of participants will be recorded

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 ≤age≤65;

    • Types of surgery: laparoscopic gynecological surgery, laparoscopic gastrointestinal surgery, thoracoscopic radical lung cancer surgery;

    • 1 h ≤ operation time ≤ 3 h;

    • ASA grade I~III;

    • BMI of 18.5~29.9 kg/m2 [BMI= weight (kg)/height (m) 2] (2013 American guidelines for the Management of Overweight and Obesity in Adults);

    • In accordance with ethics, the patient voluntarily took the test and signed the informed consent.

    Exclusion Criteria:

    • Cerebral vascular accident, such as stroke, transient ischemic attack (TIA), etc. within 3 months;

    • Severe abnormal liver and kidney function (severe abnormal liver function: ALT, AST, ALP, total bilirubin, one of which is more than 2 times the upper limit of normal value. Severe renal dysfunction: creatinine > 2 times upper normal);

    • Patients with diabetic complications (diabetic ketoacidosis, hyperotonic coma, various infections, macrovascular disease, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);

    • Unstable angina pectoris or myocardial infarction occurred within 3 months;

    • Preoperative blood pressure ≥160/100 mmHg ( ≥ Grade 2 hypertension, 2020 ISH Hypertension Guidelines);

    • Identified/suspected abuse or long-term use of narcotic sedatives and analgesics; •Taking hormones or other immunosuppressive agents for more than 10 days within half a year, or having a history of adrenocortical suppression or immune system diseases;

    • Hypothyroidism;

    • Patients with a history of asthma;

    • Those who were reoperated within 3 months;

    • Having contraindications or allergies to test drugs and other narcotic drugs;

    • Patients enrolled in other studies within 30 days.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henan Provincial People's Hospital Zhengzhou Henan China 450003

    Sponsors and Collaborators

    • Henan Provincial People's Hospital

    Investigators

    • Study Chair: Jiaqiang Zhang, PHD, Henan Provincial People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Henan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05223907
    Other Study ID Numbers:
    • ytmz
    First Posted:
    Feb 4, 2022
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Henan Provincial People's Hospital
    etomidate
    propofol
    anesthesia maintenance
    sevoflurane
    anesthesia quality
    Additional relevant MeSH terms:
    Propofol
    Etomidate

    Study Results

    No Results Posted as of Feb 4, 2022