Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion During Rigid Bronchoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Percentage of time with BIS in the desired range
研究概览
简要总结
The purpose of this study is to compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during rigid bronchoscopy.
详细描述
The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We have built a combined closed-loop anesthesia system using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. A recent study has shown that such system is able to provide clinically adequate anesthesia. The aim of the present study is to assess the system during rigid bronchoscopy. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain BIS between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop anesthesia system group to do similar or better.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing rigid bronchoscopy under general anesthesia
排除标准
- •pregnant women
- •allergy to propofol or remifentanil
- •neurological disorder
- •psychotrop treatment
结局指标
主要结局
Percentage of time with BIS in the desired range
时间窗: During the procedure
次要结局
- extubation time(during the procedure)
- consumption of propofol and remifentanil(during the procedure)
- explicit memorisation(postoperative day 2)
