NCT01020643已完成4 期
Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Controller performance
研究概览
简要总结
The purpose of this study is to compare the administration of a standard anesthetic drug (propofol) using an automatic, expert-based system versus a manually controlled system by the anesthesiologist. In addition, the performance of the decision support system will be evaluated.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing hip or knee replacement under spinal anesthesia
排除标准
- •contraindication to spinal anesthesia
- •allergies to any study drug
研究组 & 干预措施
controlled sedation using propofol
Experimental
干预措施: controlled administration of propofol (Drug)
结局指标
主要结局
Controller performance
时间窗: 1 year
次要结局
- fluid management(end of surgery)
研究者
Thomas Hemmerling
MSc, MD, DEAA,
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (1)
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