A Comparison of Accelerometric Monitoring by TOF Watch® SX and Electromyographic Monitoring by Tetragraph® for Recovery From Neuromuscular Blockade
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios
研究概览
简要总结
This observational study was designed to assess the agreement between the recently marketed electromyographic neuromuscular blockade monitor Tetragraph® (Senzime, Uppsala, Sweden) and the TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland), an accelerometric neuromuscular blockade monitor frequently used in clinical practice
详细描述
Before the induction of general anesthesia both monitors will be placed in the same arm. After induction of general anesthesia and before neuromuscular blocking agent administration both devices will be consecutively calibrated and a baseline measurement will be obtained. During the surgical procedure the investigators will monitor neuromuscular function with one of the two devices. Then the investigators will switch the device used as a guide between subsequent patients. The protocol will start as soon as the leading device will register a train-of-four ratio (TOFr) ≥ 0.2. During the protocol a comparison between the two devices will be conducted as soon as the device used as a guide will display a TOFr ≥ 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1. For each of the TOFr reported, we will deliver two subsequent TOF stimulations with the guiding device followed by two TOF stimulations with the other monitor. Both the stimulations delivered by each device and the two consecutive stimulations delivered by different monitors will be conducted 20 sec from one another. Stimulations with the same device will be used to assess intraobserver variability for each methodology, while the second and the third measurements (consecutive stimulations with different devices) will be used to assess agreement between them. The protocol will end when the leading device will show a TOFr ≥ 1.0, or if, at the end of the surgical procedure, acceleromyographic TOFr will be > 0.9.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years
- •Rocuronium bromide use is anticipated for neuromuscular blockade during surgical procedure
- •Upper arms will be freely available during the surgical procedure
排除标准
- •Known neuromuscular disease
- •Known allergy to Rocuronium bromide
- •end-stage liver disease
- •chronic kidney disease
结局指标
主要结局
Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios
时间窗: Recovery from neuromuscular blockade at the end of the surgical procedure
Bias and Limits of Agreement between the two methodologies using Bland-Altman analysis
次要结局
- Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios < 0.8(Recovery from neuromuscular blockade at the end of the surgical procedure)
- Absolute and relative intraobserver variability for TOF Watch® SX and Tetragraph®(Recovery from neuromuscular blockade at the end of the surgical procedure)
- Agreement between normalized TOF Watch® SX and Tetragraph® train-of-four ratios(Recovery from neuromuscular blockade at the end of the surgical procedure)
- Agreement between TOF Watch® SX and Tetragraph® train-of-four ratios for TOF ratios ≥ 0.8(Recovery from neuromuscular blockade at the end of the surgical procedure)
