the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,500
- 主要终点
- vital signs change
研究概览
简要总结
Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. Remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in ICU small short time operation.The purpose of this study is to determine (1) whether remifentanil is effective in small short time operations in ICU or not, (2) the save range of remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens in these operations.
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
- Single (Participant)
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
- •critically ill patients need endotracheal intubation
- •tracheotomy
- •central venous puncture
- •pleural puncture
- •abdominal puncture
- •lumbar puncture
- •bone marrow puncture
- •fiber bronchoscopic examination
- •other small short-time operations
排除标准
- •patients allergic to opioids
- •in pregnancy or in feeding
- •with myasthenia gravis
- •with hypovolemia,
- •take monoamine oxidase inhibitor(MAOI) in 14days
- •in coma and GCS<8
- •with bradycardia or hypotension
研究组 & 干预措施
Remifentanil
injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished.
干预措施: Remifentanil (Drug)
Remifentanil
injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished.
干预措施: Midazolam (Drug)
Lidocaine
injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
干预措施: Lidocaine (Drug)
Lidocaine
injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
干预措施: Midazolam (Drug)
Remifentanil+Lidocaine
injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished
- injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
干预措施: Remifentanil+Lidocaine (Drug)
Remifentanil+Lidocaine
injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished
- injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
干预措施: Midazolam (Drug)
结局指标
主要结局
vital signs change
时间窗: baseline, intraoperative and 10mins after operation
Richmond Agitation-Sedation Scale(RASS)
次要结局
- number of adverse reaction(baseline,intraoperative,10mins after operation,30mins after operation)
研究者
Rongqi Sun
The director of SICU,Chief physician,professor
The First Affiliated Hospital of Zhengzhou University