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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sugammadex, Motor Evoked Potentials

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |