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

Minyu Jian, Bo Ma, Haiyang Liu, Chengwei Wang, Fa Liang, Yang Zhou, Hui Qiao, Ruquan Han, Minyu Jian, Bo Ma, Haiyang Liu, Chengwei Wang, Fa Liang, Yang Zhou, Hui Qiao, Ruquan Han

Abstract

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.

Keywords: adult anaesthesia; neurophysiology; neurosurgery.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consolidated standards of reporting trials flow diagram for this trial. TceMEPs, transcranial motor-evoked potentials.

References

    1. Hadley MN, Shank CD, Rozzelle CJ, et al. . Guidelines for the use of electrophysiological monitoring for surgery of the human spinal column and spinal cord. Neurosurgery 2017;81:713–32. 10.1093/neuros/nyx466
    1. Macdonald DB, Skinner S, Shils J, et al. . Intraoperative motor evoked potential monitoring - a position statement by the American Society of Neurophysiological Monitoring. Clin Neurophysiol 2013;124:2291–316. 10.1016/j.clinph.2013.07.025
    1. Walker CT, Kim HJ, Park P, et al. . Neuroanesthesia guidelines for optimizing transcranial motor evoked potential neuromonitoring during deformity and complex spinal surgery: a Delphi consensus study. Spine 2020;45:911–20. 10.1097/BRS.0000000000003433
    1. Liu H-Y, Zeng H-Y, Cheng H, et al. . Comparison of the effects of etomidate and propofol combined with remifentanil and guided by comparable bis on transcranial electrical motor-evoked potentials during spinal surgery. J Neurosurg Anesthesiol 2012;24:133–8. 10.1097/ANA.0b013e31823dfb2e
    1. Kim S-H, Jin S-J, Karm M-H, et al. . Comparison of false-negative/positive results of intraoperative evoked potential monitoring between NO and partial neuromuscular blockade in patients receiving propofol/remifentanil-based anesthesia during cerebral aneurysm clipping surgery: a retrospective analysis of 685 patients. Medicine 2016;95:e4725. 10.1097/MD.0000000000004725
    1. Kim WH, Lee JJ, Lee SM, et al. . Comparison of motor-evoked potentials monitoring in response to transcranial electrical stimulation in subjects undergoing neurosurgery with partial vs no neuromuscular block. Br J Anaesth 2013;110:567–76. 10.1093/bja/aes395
    1. van Dongen EP, ter Beek HT, Schepens MA, et al. . Within-patient variability of myogenic motor-evoked potentials to multipulse transcranial electrical stimulation during two levels of partial neuromuscular blockade in aortic surgery. Anesth Analg 1999;88:22–7. 10.1213/00000539-199901000-00005
    1. Kalkman CJ, Drummond JC, Kennelly NA, et al. . Intraoperative monitoring of tibialis anterior muscle motor evoked responses to transcranial electrical stimulation during partial neuromuscular blockade. Anesth Analg 1992;75:584–9. 10.1213/00000539-199210000-00021
    1. Liu H-Y, Xia T-J, Zhu Z-Z, et al. . Effect of neuromuscular blockade on transcranial electric motor evoked potentials during surgical correction for idiopathic scoliosis under total intravenous anesthesia. J Clin Monit Comput 2019;33:471–9. 10.1007/s10877-018-0182-8
    1. Kovac AL. Sugammadex: the first selective binding reversal agent for neuromuscular block. J Clin Anesth 2009;21:444–53. 10.1016/j.jclinane.2009.05.002
    1. Brett K, Farrah K. CADTH rapid response reports. Sugammadex for the reversal of Rocuronium-Induced neuromuscular blockade in surgical patients: a review of clinical effectiveness. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health Copyright © 2019 Canadian Agency for Drugs and Technologies in Health, 2019.
    1. Togioka BM, Yanez D, Aziz MF, et al. . Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery. Br J Anaesth 2020;124:553–61. 10.1016/j.bja.2020.01.016
    1. Krause M, McWilliams SK, Bullard KJ, et al. . Neostigmine versus Sugammadex for reversal of neuromuscular blockade and effects on Reintubation for respiratory failure or newly initiated noninvasive ventilation: an interrupted time series design. Anesth Analg 2020;131:141–51. 10.1213/ANE.0000000000004505
    1. Pavoni V, Gianesello L, De Scisciolo G, et al. . Reversal of profound and "deep" residual rocuronium-induced neuromuscular blockade by sugammadex: a neurophysiological study. Minerva Anestesiol 2012;78:542–9.
    1. Honing G, Martini CH, Bom A, et al. . Safety of sugammadex for reversal of neuromuscular block. Expert Opin Drug Saf 2019;18:883–91. 10.1080/14740338.2019.1649393
    1. Becker J, Jehna M, Steinmann E, et al. . The sensory-motor profile awake-A new tool for pre-, intra-, and postoperative assessment of sensory-motor function. Clin Neurol Neurosurg 2016;147:39–45. 10.1016/j.clineuro.2016.05.022
    1. Kawaguchi M, Iida H, Tanaka S, et al. . A practical guide for anesthetic management during intraoperative motor evoked potential monitoring. J Anesth 2020;34:5–28. 10.1007/s00540-019-02698-2
    1. Godai K, Hasegawa-Moriyama M, Kuniyoshi T, et al. . Three cases of suspected sugammadex-induced hypersensitivity reactions. Br J Anaesth 2012;109:216–8. 10.1093/bja/aes137
    1. Mendiratta A, Emerson RG. Neurophysiologic intraoperative monitoring of scoliosis surgery. J Clin Neurophysiol 2009;26:62–9. 10.1097/WNP.0b013e31819f9049
    1. Hemmer LB, Zeeni C, Bebawy JF, et al. . The incidence of unacceptable movement with motor evoked potentials during craniotomy for aneurysm clipping. World Neurosurg 2014;81:99–104. 10.1016/j.wneu.2012.05.034
    1. Selner AN, Ivanov AA, Esfahani DR, et al. . Feasibility of full neuromuscular blockade during transcranial motor evoked potential monitoring of neurosurgical procedures. J Neurosurg Anesthesiol 2022;34:69–73. 10.1097/ANA.0000000000000696
    1. Batistaki C, Papadopoulos K, Kalimeris KA, et al. . Sugammadex to reverse rocuronium and facilitate intraoperative motor evoked potentials monitoring during spinal surgery. Anaesth Intensive Care 2012;40:1073–4.

Source: PubMed

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