NCT01321203已完成不适用
A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).
Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Patient comfort post ERCP
研究概览
简要总结
To assess the safety and efficacy of CO2 insufflations during ERCP
- Primary objective:
To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group. 2. Secondary objective:
Endoscopist:
- To assess the adequacy of bowel distension for adequate luminal visualization
- To assess the peristaltic movement during the ERCP
Anesthetist:
- To measure the PCO2 level in patient post procedure.
- To assess the amount of sedation required during the procedure.
- To assess saturation and vital signs through out the procedure.
- To assess requirement of buscopan.
详细描述
mentioned in complete
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •All consecutive adult patients referred for ERCP to AIG Hyderabad
排除标准
- •Age < 18 years old excluded from the study.
- •Patients with COPD.
- •Patients with poor ejection fractions and decompensated heart failure.
- •Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.
- •Patients with recent endoscopic procedure within 24 hours.
- •Patient with history of recent surgery within 7 days of duration.
- •Pregnant patients.
- •Patients not keen to give consent for the study.
结局指标
主要结局
Patient comfort post ERCP
时间窗: 1 hour
the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )
次要结局
- Abdominal distention prior and post ERCP(5 minutes)
研究者
研究点 (1)
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