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临床试验/NCT04947306
NCT04947306已完成不适用

A Comparison of Accelerometric Monitoring by TOF Watch® SX and Electromyographic Monitoring by Tetragraph® for Recovery From Neuromuscular Blockade

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年8月24日最近更新:
适应症

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

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)

研究者

发起方
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
申办方类型
Other
责任方
Sponsor

研究点 (1)

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