Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
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
- Cognitive impairment at hospital discharge after elective outpatient colonoscopy
研究概览
简要总结
Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects.
200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.
详细描述
A great variety of drug combinations are administered to patients having elective outpatient colonoscopy. In addition, as patients are going home, some may have residual cognitive deficits that making leaving the hospital unsafe. This study aims to find drugs combinations that are associated with the least cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation
排除标准
- •No cognitive impairment
- •Adequate English language comprehension
- •Not combined with other procedures
研究组 & 干预措施
1
These patients will only receive intravenous propofol which will be titrated to an OAA/S score of 3. They will not receive fentanyl, midazolam or any other drugs
干预措施: Propofol, midazolam, fentanyl (Drug)
2
These patients will receive propofol plus midazolam and/or fentanyl. Midazolam and fentanyl will be given in fixed doses first and propofol will be titrated to effect. All drugs will be given intravenously.
干预措施: Propofol, midazolam, fentanyl (Drug)
结局指标
主要结局
Cognitive impairment at hospital discharge after elective outpatient colonoscopy
时间窗: Before discharge from daycare facility
次要结局
- Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care(Before discharge from daycare facility)