Effects of Etomidate/Propofol Mixture or Propofol Monotherapy With Different Proportions on Circulation and Prognosis in Patients Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- blood pressure
研究概览
简要总结
The purpose of this study was to investigate the effects of different proportions of etomidate/propofol mixture and propofol alone intravenous anesthesia on intraoperative and postoperative physiological indicators and complications, and to find out the optimal use ratio of E/P mixture.
详细描述
Propofol is one of the most commonly used intravenous anesthesia drugs clinically, the pharmacokinetic characteristics makes it very suitable for total intravenous anesthesia( TIVA), etomidate belongs to intravenous anesthesia with propofol, is a derivative of the imidazoles, its calm performance is strong, work quickly, no obvious respiratory depression, had little effects on the cardiovascular system, which, therefore, to protect the cardiovascular, maintain hemodynamic stability has a certain advantage. Our previous project showed that propofol and etomidate combined application can maintain stable hemodynamics in patients with better, reduce the occurrence of adverse reactions, can be used within 3 h of surgery anesthesia.The purpose of this study is to use propofol or etomidate/propofol mixture in combination with BIS monitoring to perform general anesthesia maintenance for patients, in order to ensure the appropriate depth of anesthesia, better maintain the hemodynamic stability of patients, reduce adverse reactions, and find the appropriate E/P mixture of the best proportion and dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (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
- •Patients undergoing elective general anesthesia surgery in 3h;
- •American Society of Anesthesiologists gradesⅠ~III;
- •Aged 18 to 65 years, Body Mass Index 18.5 ~ 29.9kg / m2;
- •Hemoglobin 100 ~ 125g / L.
- •In line with the ethics, the patients volunteered to take the test and signed the informed consent
排除标准
- •Identify or suspect abuse or chronic use of narcotic sedatives and analgesics;
- •Heart, or liver, or lung, or kidney dysfunction;
- •Body mass index> 30kg / m2; or <18.5kg / m2
- •Speech, hearing or mental disorders;
- •severe diabetes, hyperkalemia ;
- •participate in other drug clinical researches in four weeks;
- •Poor compliance, can not complete clinical research by research program.
- •Any cerebrovascular accident occurred within 3 months, such as stroke, TIA, etc
- •Unstable angina and myocardial infarction occurred within 3 months;
- •Having contraindications or allergies to experimental drugs and other narcotic drugs;
- •Mental illness, hyperkalemia.
研究组 & 干预措施
Group A
Propofol 20 mg/ml, recommended anesthesia induction dose of 0.1~0.125 ml/kg, anesthesia maintenance pump speed of 0.2~0.5ml/kg/h. keep bispectral index within 40 # 60
干预措施: Propofol 20 MG/ML (Drug)
GroupB
EP1:3, that is, 10ml etomidate was mixed with 30ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.
干预措施: Propofol 20 mg/ml , etomidate 2 mg/ml (Drug)
Group C
EP1:1, that is, 20ml etomidate was mixed with 20ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.
干预措施: Propofol 20 mg/ml , etomidate 2 mg/ml (Drug)
Group D
EP3:1, that is, 30ml etomidate was mixed with 10ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.
干预措施: Propofol 20 mg/ml , etomidate 2 mg/ml (Drug)
结局指标
主要结局
blood pressure
时间窗: intraoperative
the blood pressure is recorded (mmHg)
heart rate
时间窗: intraoperative
the heart rate is recorded(bpm)
次要结局
- Perioperative complications(intraoperative)
研究者
Guolin Wang
Tianjin Medical University General Hospital
Tianjin Medical University General Hospital