Safety and Efficacy of Maintenance of Etomidate in General Anesthesia
- Registration Number
- NCT05223907
- Lead Sponsor
- Henan Provincial People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1080
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Propofol Propofol Propofol will be used for general anesthesia Group Etomidate Etomidate Etomidate will be used for general anesthesia
- Primary Outcome Measures
Name Time Method Rate of intraoperative hypertension and hypotension From the beginning to the end of surgery Investigators will record the rate of hypertension and hypotension of participants during intraoperative period
Ricker sedation-agitation score after surgery 1 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 Outcome Measures
Name Time Method The incidence of PONV One-three days after surgery. The incidence of postoperative nausea and vomiting of participants will be recorded
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)
Trial Locations
- Locations (1)
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China