Safety and Efficacy of Maintenance of Etomidate Combined With Sevoflurane in General Anesthesia: a Multi-center Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Rate of intraoperative hypertension and hypotension
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group Etomidate
Etomidate will be used for general anesthesia
干预措施: Etomidate (Drug)
Group Propofol
Propofol will be used for general anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
Rate of intraoperative hypertension and hypotension
时间窗: 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
时间窗: 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
次要结局
- The incidence of PONV(One-three days after surgery.)
- Postoperative pain scores measured by VAS score.(One-three days after surgery.)