NCT03388151Unknown3 期
Effect of Use of Propofol Versus Use of Midazolam as Sedative Agent in Patients With Liver Cirrhosis Presented for Lower Gastrointestinal Endoscopy, Randomised Controlled Trial
Sherief Abd-Elsalam1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients adequately sedated
研究概览
简要总结
propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy
详细描述
Effect of use of propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy, Randomised controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis
- •presented to colonoscopy
排除标准
- •Encephalopathy
- •Hypersensitivity
- •Coagulopathy
研究组 & 干预措施
Midazolam
Active Comparator
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
干预措施: Midazolam (Drug)
Propofol
Active Comparator
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation
干预措施: Propofol (Drug)
结局指标
主要结局
Number of patients adequately sedated
时间窗: 6 months
The number of patients adequately sedated
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
PhDTropical Medicine
Tanta University
研究点 (1)
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