Clinical trial NCT05223907: Safety and Efficacy of Maintenance of Etomidate in General Anesthesia
Official title: Safety and Efficacy of Maintenance of Etomidate Combined With Sevoflurane in General Anesthesia: a Multi-center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Anesthesia
Keywords: etomidate
propofol
anesthesia maintenance
sevoflurane
anesthesia quality
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of intraoperative hypertension and hypotension
timeFrame: From the beginning to the end of surgery
measure: Ricker sedation-agitation score after surgery
timeFrame: 1 day (The period during patients wake up after surgery and general anesthesia in the recovery room.)
Secondary outcomes:
measure: Postoperative pain scores measured by VAS score.
timeFrame: One-three days after surgery.
measure: The incidence of PONV
timeFrame: One-three days after surgery.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Jiaqiang Zhang, PHD
role: STUDY_CHAIR
References: