Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223907
• Other study ID #: ytmz
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2024
• Source: Henan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Drug:
• Etomidate
Etomidate will be used for general anesthesia
• Propofol
Propofol will be used for general anesthesia

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	The incidence of PONV	The incidence of postoperative nausea and vomiting of participants will be recorded	One-three days after surgery.