The TOF3D Mechanomyograph. Evaluation of a New Device for Assessment of the Neuromuscular Block.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- difference in time to recovery to a train of four ratio of 1,0.
研究概览
简要总结
In clinical anesthesiologic practice, most institutions use acceleromyography in order to assess the degree of a neuromuscular block.
The aim of the present study is to assess a new device using mechanomyography. Until recently, this method was reserved for experimental settings. It seems to be able to work more precisely, and additionally, it offers the opportunity to use other stimulation patterns than acceleromyographic measurements.
The investigation is divided into two parts:
Part 1 compares the mechanomyograph directly with an acceleromyograph. In part 2, two mechanomyographs using different stimulation patterns are compared with each other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for surgery requiring general anesthesia with neuromuscular blocking agents
排除标准
- •anticipated or known difficult airway
- •increased risk for aspiration
- •pregnancy
- •neuromuscular disorders
研究组 & 干预措施
comparison of mechanomyograph and acceleromyograph
干预措施: measurement of the time course of a neuromuscular block (Device)
comparison of tetanic fade versus train of four ratio
干预措施: measurement of the time course of a neuromuscular block (Device)
结局指标
主要结局
difference in time to recovery to a train of four ratio of 1,0.
时间窗: from enrollment to the end of anesthesiologic treatment at the day of surgery (2-3 weeks after enrollment)
difference in time to recovery to a train of four ratio of 1,0 measured by acceleromyography and mechanomyography, respectively
次要结局
未报告次要终点