Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- post-procedural pain
研究概览
简要总结
Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy.
The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD
排除标准
- •age < 18 or > 70 years
- •pregnancy
- •breast feeding
- •chronic obstructive lung disease (COPD)
- •known CO2 retention and refusal to participate in the study
结局指标
主要结局
post-procedural pain
时间窗: 3 months
The primary end point of the study was to assess post-procedural pain according to VAS scale
次要结局
- abdominal distention(3 months)
- ETCO2(3 months)
研究者
Eun Hee Seo, MD
principal investigator
Inje University