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临床试验/NCT05224648
NCT05224648已完成不适用

Comparison of Train of Four, Tetanus 50 Hz and Tetanus 100 Hz Recovery Following Rocuronium Induced Neuromuscular Block Reversed by Neostigmine

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
To determine the delay following neostigmine administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9

研究概览

简要总结

Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio threshold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.

Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by an anticholinesterase agent (neostigmine). Neostigmine will be injected once four muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with the clinical practice worldwide admitted.

Two questions have to be investigated. First, is this dose of neostigmine sufficient to allow a complete recovery of tetanus stimulations ? Second, due to the pharmacological properties of neostigmine, does a recurarisation phenomenon occur following repeated tetanus stimulations ? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.

研究设计

研究类型
Interventional
分配方式
Non 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA clinical status 1 to 3 informed consent obtained before anesthesia induction

排除标准

  • ASA clinical status 4 emergency surgery scheduled surgery in prone position hepatic or renal disease BMI higher than 35 allergy to rocuronium or neostigmine

结局指标

主要结局

To determine the delay following neostigmine administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9

时间窗: 30 minutes after neostigmine administration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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