NCT00952458已完成不适用
Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Cardiopulmonary complications of sedation
研究概览
简要总结
This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation
排除标准
- •Missing informed consent
- •Preexisting neurological deficit
- •Known pregnancy
- •Hypotension (RRsys<90mmHg), bradycardia (HR<50/min), hypoxia (SaO2<90%)
结局指标
主要结局
Cardiopulmonary complications of sedation
时间窗: 1-4 hours
次要结局
- Efficacy of sedation(1-4 hours)
研究者
研究点 (2)
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