Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

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

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthesia
• Intervention / Treatment: Drug: Etomidate; Drug: Propofol

• Study Type: Interventional
• Enrollment (Anticipated): 1080
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Zhou, PHD; Phone Number: +8637187160380; Email: hnsrmyy3680@163.com
• Study Contact Backup: Name: Jiaqiang Zhang, PHD; Phone Number: +8613937121360; Email: hnmzxh@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Jun Zhou; Phone Number: +8637187160380; Email: hnsrmyy3680@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: sevoflurane; propofol; etomidate; anesthesia maintenance; anesthesia quality
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Etomidate
• Other Study ID Numbers: ytmz

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No