Rocuronium ED50 for Excellent Laparoscopic Conditions for Cholecistectomy: Dose-finding Adaptative Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Excellent laparoscopic conditions
研究概览
简要总结
This is an adaptative study where each participant's rocuronium dose will depend on the previous patient's response, being higher if it was not enough and lower if it was more than enough.
详细描述
Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax abdominal wall for laparoscopic surgery.
Rocuronium intubation dose can be enough for intubation but not last enough for excellent laparoscopic conditions. There is little variation in time from anesthesia induction to the end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help providing excellent conditions and fast track extubation.
Dixon's up-and-down method will guide this dose-finding study for the ED50.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participant receives hypnotic (propofol) before we use the drug
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •general anesthesia
排除标准
- •deny participation
研究组 & 干预措施
Dose-finding group
The first patient will receive rocuronium 0,6mg/kg. After that, every patient's dose will depend on the outcome of the previous patient. It will go up 0,1mg/kg if the laparoscopic conditions were not excellent or go down 0,1mg/kg otherwise.
干预措施: rocuronium (Drug)
结局指标
主要结局
Excellent laparoscopic conditions
时间窗: 30 minutes
Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not
次要结局
未报告次要终点
研究者
Gabriel Magalhaes Nunes Guimaraes
Head of Anesthesiology
Brasilia University Hospital