Effect of Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording

Effect of Intraoperative Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording

Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.

Study Overview

• Status: Completed
• Conditions: Sugammadex; Motor Evoked Potentials
• Intervention / Treatment: Drug: Sugammadex; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age range from 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical status I to II

Exclusion Criteria:

• BMI ≥35 kg/m-2
• History of epilepsy or use of antiepileptic drugs
• Personal history or family history of malignant hyperthermia
• Allergies to sugammadex; NMBs or other medication(s) used during general anesthesia
• Hemoglobin <110 g/L
• TceMEP stimulation or recorded site infection
• Preoperative neurological dysfunction in both upper extremities
• Cardiac pacemaker
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group	Drug: Saline; The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.
Experimental: Sugammadex group	Drug: Sugammadex; The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of TceMEPs	The success rate of Transcranial motor evoked potentials monitoring（TceMEPs）	5 minutes after first performing of TceMEPs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean value of amplitudes of TceMEPs	Mean value of amplitudes of Transcranial motor evoked potentials monitoring（TceMEPs）in the abductor pollicis brevis muscles of both upper extremities	5, 10, 20, 30 and 60 minutes after first performing of TceMEPs
Mean value of latencies of TceMEPs	Mean value of latencies of Transcranial motor evoked potentials monitoring（TceMEPs） in the abductor pollicis brevis muscles of both upper extremities	5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.
Thresholds of TceMEPs	The thresholds that are required to obtain a dependable Transcranial motor evoked potentials monitoring（TceMEPs） response.	5 minutes after first performing of TceMEPs
respiratory pressure	Peak respiratory pressures	during the surgery
Adverse effects of sugammadex	Adverse effects of sugammadex such as anaphylaxis (including flushing, oedema, tachycardia and bronchospasm), arrhythmias (heart rate lower than 60bpm), postprocedural pain, nausea and vomiting, fever (body temperature more than 37.3℃ ), and diarrhea, etc	during the surgery
Incidence of body movement	Incidence of body movement classified as either nociception-induced movement (defined as "coughing" or reflexive limb movement temporally related to MEP stimulation) or excessive field movement (defined as grossly visible movement as determined by surgical and anaesthesia teams).	during the surgery
Recurrence of neuromuscular blockade	Recurrence of neuromuscular blockade defined as TOFr < 0.9	time of extubation

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Publications and helpful links

General Publications

• Jian M, Ma B, Liu H, Wang C, Liang F, Zhou Y, Qiao H, Han R. 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. BMJ Open. 2022 May 2;12(5):e056571. doi: 10.1136/bmjopen-2021-056571.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 25, 2020
• First Submitted That Met QC Criteria: October 25, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: WJP20201030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 3 months after the study is finished
• IPD Sharing Access Criteria: principal investigator
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No