Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will be compared regarding recovery time and other parameters described below.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age more than 18
- •candidate for a painful procedure
- •negative past history of a serious medical condition
- •ASA score 0 and 1
排除标准
- •deep sedation making the patient unable to answer the questions
- •pregnancy
- •allergy to drugs
- •hemodynamic instability
- •failure to consent
研究组 & 干预措施
Propofol
The patients will receive propofol for sedation in addition to fentanyl
干预措施: Propofol (Drug)
Propofol
The patients will receive propofol for sedation in addition to fentanyl
干预措施: Fentanyl (Drug)
Midazolam
The patients will receive midazolam for sedation in addition to fentanyl
干预措施: Midazolam (Drug)
Midazolam
The patients will receive midazolam for sedation in addition to fentanyl
干预措施: Fentanyl (Drug)
结局指标
主要结局
Recovery time
时间窗: Within one hour after sedation
Length of time before complete recovery from sedation is achieved
次要结局
- Patients' Pain perception(Within one hour after sedation)