Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

NCT ID: NCT05223907

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1080 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-12-31

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.

Conditions

General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group Etomidate

Etomidate will be used for general anesthesia

Group Type: EXPERIMENTAL

Etomidate

Intervention Type: DRUG

Etomidate will be used for general anesthesia

Group Propofol

Propofol will be used for general anesthesia

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Propofol will be used for general anesthesia

Interventions

Etomidate

Etomidate will be used for general anesthesia

Intervention Type: DRUG

Propofol

Propofol will be used for general anesthesia

Intervention Type: DRUG

Other Intervention Names

Etomidate Injectable Emulsion; Yituomizhi, H20020511, WS-400(X-338)-2002-2015Z,YT211101; Diprivan, JX20060102，H20080473，RW981

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiaqiang Zhang, PHD

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Locations

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

ytmz

Identifier Type: -

Identifier Source: org_study_id