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临床试验/NCT06220136
NCT06220136已完成不适用

Comparison of the Performances of the Train-of-Four Ratio and the Modified Train-of-Four Ratio During Reversal of Deep Neuromuscular Blockade With Sugammadex

Ankara University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
time

研究概览

简要总结

It is known that deep neuromuscular block improves surgical conditions, especially during laparoscopic abdominal surgery. Based on this, in the Perioperative Neuromuscular Blockade Management guide published by the ESAIC association in 2022, it is recommended to deepen the level of neuromuscular blockade in cases where surgical conditions need to be improved. Sugammadex should be used to quickly and reliably reverse deep neuromuscular blockade. TOFScan, a 3-dimensional acceleromyograph for neuromuscular monitoring, has become widely used in recent years. With this monitor, it has been shown that in addition to the classical train-of-four ratio (cTOFR), the modified train-of-four ratio (mTOFR) can be used during the spontaneous recovery of nondepolarizing neuromuscular blockade. In a study conducted by Schmartz et al. in 2021, it was shown that mTOFR, which is the ratio of T4 to the reference stimulus, was compiled later than cTOFR. Therefore, it is suggested that the mTOFR value is a better determinant for safe extubation.

详细描述

Neuromuscular blockers (NMB) agents are commonly used drugs in anesthesia for facilitating airway management, improving surgical conditions, and inducing immobility in critical situations. As a natural consequence of their use, postoperative residual neuromuscular block has been associated with serious postoperative complications such as upper airway obstruction, reintubation, atelectasis, pneumonia, prolonged stay in the post-anesthesia care unit (PACU), and decreased patient satisfaction. The incidence of residual block at the end of surgery and/or in the PACU is approximately 64% according to the literature .

Various factors contribute to the high incidence of residual neuromuscular block, including variability in the duration of action of neuromuscular blocker agents, variability in the time it takes for antagonist drugs to restore neuromuscular function, and clinicians' reliance on unreliable methods for assessing neuromuscular strength, such as continuous head lifting, grip strength, or respiratory measurements (e.g., tidal volume, inspiratory force), and the subjective evaluation of peripheral nerve stimulation responses . Residual neuromuscular block is a significant patient safety concern, and its detection and risk reduction are crucial for improving patient outcomes. One of the objective methods for assessing neuromuscular function is the Train of Four (TOF), which is an acceleromyographic peripheral nerve stimulator.

The effectiveness of TOF as an objective and quantitative assessment of neuromuscular block and its role in reducing postoperative complications has been demonstrated in numerous studies. In 2023, the "American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade" presented it with a moderate level of evidence and a high recommendation level. Likewise, in 2023, the European Society of Anesthesiology and Intensive Care's "Perioperative Management of Neuromuscular Blockade" guideline recommended TOF monitoring as part of routine perioperative monitoring with a 1B level of evidence .

TOF involves delivering four brief electrical impulses to a peripheral nerve at a frequency of 2 Hz and evaluating the resulting "twitches." The ratio of the response to the fourth stimulus to the response to the first stimulus (T4/T1) is referred to as the TOF ratio. Acceptable recovery of neuromuscular function is defined as a TOF ratio greater than or equal to 0.9. In a prospective study conducted in 2022 by Schmartz and colleagues, they compared a modified TOF ratio (T4/Tr) to the classic TOF ratio (T4/T1) against a reference measurement and demonstrated that the T4/Tr ratio is a better indicator of readiness for adequate recovery and safe extubation from non-depolarizing neuromuscular blockade compared to the classic TOF ratio (T4/T1) . This result suggests that the classic TOF ratio may overestimate the degree of true neuromuscular recovery, potentially leading to early tracheal extubation, increased risk of postoperative pulmonary complications, and endangering patient safety.

The aim of our study is to determine whether the differences in mTOF/classic TOF durations, as shown by Schmartz and colleagues in spontaneous neuromuscular recovery, also result in significant differences when rocuronium is reversed with sugammadex.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 - 65 (not including 65)
  • BMI: 18.5-24.9

排除标准

  • Liver and kidney disease
  • Non-consenting
  • Emergency surgeries
  • Muscle disease
  • Allergy to rocuronium and sugammadex
  • Patients predicted to have difficult mask ventilation or difficult intubation
  • Pregnant and breastfeeding women

研究组 & 干预措施

single group

rocuronium drug administration TOFscan monitoring administration of sugammadex drug recording of classical TOF and modified TOF values

干预措施: TOFscan monitoring (Device)

结局指标

主要结局

time

时间窗: 15 minutes

Comparison of classical and modified TOF rates to reach 90% and above

次要结局

  • time(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Güneş Yeşilova, MD

Research assistant

Ankara University

研究点 (1)

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