Carbon Dioxide Insufflations vs. Air Insufflation in Therapeutic ERCP: A Randomized Double-blind Comparative Study Depending on Sedation Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Sedation quality
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients without complications, compared with air insufflation. However, differences in patient suffering between CO2 and air insufflation after ERCP depending on sedation protocols have not been reported. We therefore planned prospective, double-blind, randomized, controlled study with CO2 and air insufflation during ERCP depending on sedation protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •candidates for therapeutic ERCP
排除标准
- •age<18 years
- •pregnant women
- •total gastrectomy
- •uncontrolled coagulopathy
- •American Society of Anesthesiologist(ASA) Class V
- •neurologic impairment
- •known allergy to the drugs used
- •history of complications with previous sedation, sedative
- •alcohol abuse
- •inability to provide informed consent
结局指标
主要结局
Sedation quality
时间窗: After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later
Abdominal pain, discomfort, and gas accumulation
次要结局
- Procedure outcome(After completion of procedure, within 2hrs)
- Complications(After completion of procedures (within 2 hrs) and 24 hrs later)
研究者
Tae Hoon Lee
Professor
Soon Chun Hyang University