Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The prevalence of paradoxical response
研究概览
简要总结
This study is to compare propofol vs. midazolam with propofol for sedative endoscopy in patients with previous paradoxical reaction to midazolam. Patients who meet eligibility criteria will randomly assigned to propofol group or midazolam with propofol group. Then they will receive a sedative endoscopy with close monitoring. The primary outcome is the prevalence of paradoxical response during endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of midazolam-induced paradoxical response
排除标准
- •Failed to obtain informed consent
- •Pregnant or breast feeding women
- •A severe cardiopulmonary or vascular disease with symptoms
- •Cognitive or mental impairment
研究组 & 干预措施
Midazolam with propofol
Participants who receive midazolam + propofol during sedative endoscopy.
干预措施: Midazolam (Drug)
Propofol alone
Participants who receive propofol alone during sedative endoscopy.
干预措施: Propofol (Drug)
Midazolam with propofol
Participants who receive midazolam + propofol during sedative endoscopy.
干预措施: Propofol (Drug)
结局指标
主要结局
The prevalence of paradoxical response
时间窗: At the end of endoscopy
The proportion of participants who show paradoxical response during endoscopy
次要结局
未报告次要终点
研究者
Dong Kee Jang
Assistant Professor
DongGuk University