2023-503470-21-00已完成4 期
Efficacy of Remimazolam with Fentanyl versus Midazolam with Fentanyl for sedation in screening colonoscopy: A randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total time from start of medication to fulfillment of the discharge criteria
研究概览
简要总结
The overall object of this project is to investigate Remimazolam with Fentanyl compared to Midazolam with Fentanyl for sedation in screening colonoscopy with the primary outcome being total time from start of medication to fulfillment of the discharge criteria. In this way we will examine whether Remimazolam with Fentanyl could create an improvement in procedural sedation by leading to both a shorter procedure as well as shorter recovery time.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age over 18
- •Scheduled for elective colonoscopy screening for colon cancer
- •Must be able to provide informed written consent.
排除标准
- •Requiring general anesthesia.
- •Allergy to Midazolam, Remimazolam, opioids or ingredients.
结局指标
主要结局
Total time from start of medication to fulfillment of the discharge criteria
Total time from start of medication to fulfillment of the discharge criteria
次要结局
- Need for postprocedural recovery room, due to lack of fulfillment of discharge criteria.
- Patient discomfort/pain rated using NRS-11.
- Time to reach coecum.
- Need for additional Fentanyl.
- Need for additional sedativa.
- Patient satisfaction.
- Endoscopist satisfaction
- Cognitive function at discharge.
研究者
Andrea Ambrecht
Scientific
Herlev Hospital
研究点 (1)
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