术中肌肉松弛逆转对脊柱手术患者运动诱发电位记录成功率的影响：一项随机对照试验的研究方案。
Effect of intraoperative muscle relaxation reversal on the success rate of motor-evoked potential recording in patients undergoing spinal surgery: study protocol for a randomised controlled trial.
机构信息
Department of Anesthesiology, Beijing Tiantan Hospital, Beijing, China.
Department of Electrophysiology, Beijing Neurosurgical Institute, Beijing, China.
出版信息
BMJ Open. 2022 May 2;12(5):e056571. doi: 10.1136/bmjopen-2021-056571.
INTRODUCTION
Transcranial motor-evoked potentials (TceMEPs) is conventionally performed without neuromuscular blockade (NMB) because of its potential interference with neuromuscular junction and signal interpretation. Sugammadex is the first highly selective antagonist that binds to rocuronium and can rapidly and effectively reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.
METHODS AND ANALYSIS
We will conduct a single-centre randomised controlled study. In total, 162 patients undergoing thoracic or lumbar spinal surgery will be randomly divided into the sugammadex group or control group at a ratio of 1:1. Total intravenous anaesthesia by propofol and remifentanil will be performed in both groups. In the sugammadex group, patients will receive continuous infusion of rocuronium to produce a blockade maintained for at least two twitches in train-of-four, rocuronium infusion will be discontinued and 2 mg/kg sugammadex will be given while performing TceMEPs monitoring. In the control group, rocuronium infusion will be discontinued and the same volume of saline will be infused while performing TceMEPs monitoring. The primary aim of this study is to evaluate the success rate of TceMEPs recording between two groups.
ETHICS AND DISSEMINATION
The approval for the study was certificated by the Ethical Committee of Beijing Tiantan Hospital, Capital Medical University on, 16 July 2021 (KY2021-082-02). The study was registered on clincaltrials.gov on 25 October 2020. Our study might guide neuromuscular blockade plans in TceMEPs monitoring undergoing spinal surgery. The findings of the study will be published in peer-reviewed journals and will be presented at national or international conference.
TRIAL REGISTRATION NUMBER
NCT04608682.
简介
传统上，由于其对神经肌肉接头的潜在干扰和信号解读的影响，经颅运动诱发电位（TceMEP）在无神经肌肉阻滞（NMB）的情况下进行。Sugammadex 是第一个与罗库溴铵结合的高选择性拮抗剂，可快速有效地逆转 NMB。本研究旨在评估 sugammadex 对术中 TceMEP 记录的术中肌肉松弛逆转的成功率。
方法与分析
我们将进行一项单中心随机对照研究。总共将有 162 名接受胸腰椎手术的患者以 1:1 的比例随机分为 sugammadex 组或对照组。两组均采用丙泊酚和瑞芬太尼全静脉麻醉。在 sugammadex 组，患者将接受罗库溴铵持续输注，以产生至少两个强直刺激的四个成串刺激的两个抽搐维持的阻滞，停止罗库溴铵输注，并在进行 TceMEP 监测时给予 2mg/kg sugammadex。在对照组，停止罗库溴铵输注，并在进行 TceMEP 监测时输注相同体积的生理盐水。本研究的主要目的是评估两组之间 TceMEP 记录的成功率。
伦理与传播
该研究于 2021 年 7 月 16 日获得首都医科大学附属北京天坛医院伦理委员会的批准（KY2021-082-02）。该研究于 2020 年 10 月 25 日在 clincaltrials.gov 注册。我们的研究可能会指导脊柱手术中 TceMEP 监测的神经肌肉阻滞计划。该研究的结果将发表在同行评议的期刊上，并将在国内或国际会议上发表。
试验注册号
NCT04608682。
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