Esmolol Reduces Anesthetic Requirements Thereby Facilitating Early Extubation; a Prospective Controlled Study in Patients Undergoing Intracranial Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- systolic arterial pressure fluctuation
研究概览
简要总结
Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.
详细描述
Patients undergoing elective craniotomy for aneurysm clipping or tumor dissection were randomly divided in two groups (four subgroups). Anesthesia was induced with propofol, fentanyl and a single dose of cis-atracurium, followed by continuous infusion of remifentanil and either propofol or sevoflurane. Patients in the esmolol group received 500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol. Monitoring of the depth of anesthesia was also performed using the Bispectral Index-BIS. It was also performed monitoring of the cardiac output in order to evaluate the effect of esmolol on cardiac output.
The inspired concentration of sevoflurane and the infusion rate of propofol were adjusted in order to maintain a BIS value between 40-50.
Intraoperative emergence was detected by the elevation of BIS value, HR or MAP.
It was recorded intraoperative fluctuations of propofol and sevoflurane in both groups. Data were expressed as mean ± SD. Differences in categorical data were evaluated using the student t test.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ASA physical status 1-3
- •Glasgow Coma Scale:15
排除标准
- •Patients with ASA physical status >3,
- •Body Mass Index (BMI) over 30,
- •indication for rapid sequence induction,
- •any contraindication for receiving b-blocker,
- •chronic use of b-blocker,
- •Glasgow Coma Scale (GCS) <15,
- •history of drug abuse,
- •severe mental impairment,
- •preoperative aphasia,
- •neurologic deficit or preoperatively foreseen delayed extubation.
研究组 & 干预措施
Esmolol
500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol until 30 minutes after extubation.
干预措施: Esmolol (Drug)
Esmolol
500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol until 30 minutes after extubation.
干预措施: Propofol and sevoflurane (Drug)
control
Control group did not receive esmolol or other b-blocker in the perioperative period.
干预措施: Placebo (Drug)
结局指标
主要结局
systolic arterial pressure fluctuation
时间窗: intraoperative
次要结局
- extubation time(at time of surgery)
- Heart rate(intraoperative)
- effect of esmolol on anesthetic's concentration(intraoperative)
研究者
Asouhidou Irene
Dr.Irene Asouhidou
George Papanicolaou Hospital