NCT05553678招募中4 期
Effects of Midazolam on the Occurrence of Intraoperative Movement in Patients Undergoing Unruptured Intracranial Aneurysm Clipping Surgery: a Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Intraoperative movement
研究概览
简要总结
This study is a randomized, controlled, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery.
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
- Triple (Participant, Investigator, 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
- •Patients who undergo elective unruptured intracranial aneurysm clipping surgery
- •American Society of Anesthesiologists grade 1,2,3
- •age > 18 year old
排除标准
- •Refuse to participate to the study
- •Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- •Allergic history of benzodiazepine
研究组 & 干预措施
treatment group
Experimental
Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.
干预措施: Midazolam (Drug)
Control group
Placebo Comparator
Normal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope.
干预措施: Normal saline (Drug)
结局指标
主要结局
Intraoperative movement
时间窗: During microscopic surgery
Incidence
次要结局
- Motor evoked potential amplitude(immediately postoperative surgery)
- Satisfaction score for intraoperative environment(immediately postoperative surgery)
- Motor evoked potential Latency(immediately postoperative surgery)
- Duration of ICU stay(From date of ICU admission until the date of first discharge from ICU, assessed up to 1 week)
- Duration of mechanical ventilation time(End of surgery to extubation time)
- Postoperative delirium(Postoperative 24 hour)
研究者
Chang-Hoon Koo
Assistant professor
Seoul National University Hospital
研究点 (1)
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