Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

NCT05223907 | Completed Phase 4

• 1 other identifier: ytmz
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

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

Keywords

etomidate; propofol; anesthesia maintenance; sevoflurane; anesthesia quality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Postoperative pain scores measured by VAS score.

  One-three days after surgery.

• The incidence of PONV

  One-three days after surgery.

Study Arms (2)

Group Etomidate

EXPERIMENTAL

Etomidate will be used for general anesthesia

Drug: Etomidate

Group Propofol

EXPERIMENTAL

Propofol will be used for general anesthesia

Drug: Propofol

Interventions

Etomidate DRUG

Etomidate will be used for general anesthesia

Also known as: Etomidate Injectable Emulsion, Yituomizhi, H20020511, WS-400(X-338)-2002-2015Z,YT211101

Group Etomidate

Propofol DRUG

Propofol will be used for general anesthesia

Also known as: Diprivan, JX20060102，H20080473，RW981

Group Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤age≤65;
• Types of surgery: laparoscopic gynecological surgery, laparoscopic gastrointestinal surgery, thoracoscopic radical lung cancer surgery;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

MeSH Terms

Interventions

Etomidate; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jiaqiang Zhang, PHD

  Henan Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 4, 2022
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

CN (1)