Safety and Feasibility of a New Neuromuscular Monitoring Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four
研究概览
简要总结
The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.
The two devices will be studied simultaneously in each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients,
- •ASA class 1 to 3,
- •Scheduled for elective surgery requiring general anesthesia and muscle paralysis
排除标准
- •Age inferior to 18 years,
- •ASA class 4,
- •Emergency surgery,
- •Prone position on the operating table
结局指标
主要结局
Delay of block installation between the injection and the disappearance of all the muscular contractions to stimulation by train of four
时间窗: Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.
We compare the response to curare with one side a conventional TOF Watch SX monitor and other side Handle Isometric Thumb Force.
次要结局
- Characteristics of maintenance curarization(Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.)
- Clinical examination(the first 24 postoperative hours)
- Characteristics of decurarization during spontaneous recovery phase(Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.)
- When the TOF ratio will be greater than 0.9 on the TOF Watch side, the degree of residual paralysis will be assessed on the ITF side using 100 Hz tetanus stimulation repeated 5 times at 2 minutes interval(Usefulness of non depolarizing muscle relaxant-induced muscle paralysis is limited at the surgery period and should be avoided once the surgery is completed. Therefore, all measurements are done during this time.)