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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05223907
Enrollment
1080
Registered
2022-02-04
Start date
2021-05-01
Completion date
2022-12-31
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

etomidate, propofol, anesthesia maintenance, sevoflurane, anesthesia quality

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.

Interventions

DRUGEtomidate

Etomidate will be used for general anesthesia

DRUGPropofol

Propofol will be used for general anesthesia

Sponsors

Henan Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of intraoperative hypertension and hypotensionFrom the beginning to the end of surgeryInvestigators will record the rate of hypertension and hypotension of participants during intraoperative period
Ricker sedation-agitation score after surgery1 day (The period during patients wake up after surgery and general anesthesia in the recovery room.)Investigators will record the Ricker sedation-agitation score of participants during recovery period after general anestesia

Secondary

MeasureTime frameDescription
Postoperative pain scores measured by VAS score.One-three days after surgery.Postoperative pain scores of participants will be assessed by using VAS score (0= no pain, 10= worse pain imaginable)
The incidence of PONVOne-three days after surgery.The incidence of postoperative nausea and vomiting of participants will be recorded

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026