NCT01840371已完成不适用
Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who scheduled for ERCP
排除标准
- •The patients with ASA physical classification V
- •The patients with history of sulfite, egg or soy bean allergy
- •The patients during pregnancy or latency period
- •The patients who informed consent could not be obtained
- •The patients who were under 20 years old
研究组 & 干预措施
Propofol based group
Experimental
干预措施: Conventional sedation (Drug)
Fentanyl based group
Active Comparator
干预措施: Experimental sedation (Drug)
结局指标
主要结局
Recovery time
时间窗: time from scope withdrawal to full recovery at averange 24 hours
Recovery time (time from scope withdrawal to full recovery)
次要结局
- Adverse event during and after procedure(measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours)
研究者
研究点 (1)
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