The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 主要终点
- Heart rate
研究概览
简要总结
To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form
排除标准
- •Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days
研究组 & 干预措施
Group A
During maintenance of anesthesia, etomidate was give by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml to keep bispectral index between 40 to 60.
干预措施: etomidate (Drug)
Group B
During maintenance of anesthesia, Propofol was give by target controlled infusion, the effect-site concentration is 2 to 4 micrograms/ml to keep bispectral index between 40 to 60.
干预措施: propofol (Drug)
Group C
During maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60.
干预措施: propofol (Drug)
Group C
During maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60.
干预措施: etomidate (Drug)
结局指标
主要结局
Heart rate
时间窗: Baseline to the end of the operation, expected to be about 6 h
Heart rate should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Blood pressure
时间窗: Baseline to the end of the operation, expected to be about 6 h
Blood pressure should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.
Concentration of cortisol
时间窗: from baseline to the end of the operation, expected to be about 6 h
Concentration of cortisol should be recorded before induction, 30 min, 1 h, 2 h after intubation, and immediately when the operation is over.
次要结局
- Use of vasoactive agent(from the beginning of induction to the end of the operation, expected to be about 6 h)
- The time from stop of remifentanil to awake(The time from stop of remifentanil to awake, expected to no more than 15 min)
- Severity of agitation(Within 24 h after the operation)
- Postoperative nausea and vomiting(Within 24 h after the operation)
- Dose of etomidate and propofol(From the beginning of induction to the end of the operation, expected to be about 6 h)
- Intraoperative awareness(From the beginning of induction to the end of the operation, expected to be about 6 h)
- Expense of anesthetics(From the beginning of induction to the end of the operation, expected to be about 6 h)
- Allergic reaction(From beginning of induction to 24 h after the operation)
研究者
Liu He
Physician
Henan Provincial People's Hospital