Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Success Rate of Minimal Sedation Colonoscopy
研究概览
简要总结
Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.
This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).
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
- Single (Participant)
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
- •men and women older than 18 years referred for diagnostic outpatient colonoscopy
- •provided written consent
排除标准
- •history of colorectal surgery
- •known diagnosis of inflammatory bowel disease
- •chronic benzodiazepine use
- •refusal of minimal sedation
结局指标
主要结局
Success Rate of Minimal Sedation Colonoscopy
时间窗: 6 months
A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level \> 3 using a 7-point Likert scale \[7\] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.
次要结局
- Patient Comfort During the Procedure and During First 24 Hours After Procedure(six months)
研究者
Premysl Falt MD
Principal Investigator
Vitkovice Hospital