Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Maintenance of Etomidate Combined With Sevoflurane in General Anesthesia: a Multi-center Randomized Controlled Study

Conditions
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General Anesthesia

Intervention / Treatment
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* Drug: Etomidate
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Etomidate<br>Etomidate will be used for general anesthesia | Drug: Etomidate<br>* Etomidate will be used for general anesthesia<br>* Other names: Yituomizhi, H20020511, WS-400(X-338)-2002-2015Z,YT211101;|
| Experimental: Group Propofol<br>Propofol will be used for general anesthesia | Drug: Propofol<br>* Propofol will be used for general anesthesia<br>* Other names: Diprivan, JX20060102，H20080473，RW981;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of intraoperative hypertension and hypotension | Investigators will record the rate of hypertension and hypotension of participants during intraoperative period | From the beginning to the end of surgery | 
| Ricker sedation-agitation score after surgery | Investigators will record the Ricker sedation-agitation score of participants during recovery period after general anestesia | 1 day (The period during patients wake up after surgery and general anesthesia in the recovery room.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores measured by VAS score. | Postoperative pain scores of participants will be assessed by using VAS score (0= no pain, 10= worse pain imaginable) | One-three days after surgery. | 
| The incidence of PONV | The incidence of postoperative nausea and vomiting of participants will be recorded | One-three days after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etomidate, propofol, anesthesia maintenance, sevoflurane, anesthesia quality