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

Capital Medical University

Status: Completed

Conditions: Sugammadex; Motor Evoked Potentials

Treatments: Drug: Sugammadex; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04608682

WJP20201030

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Sugammadex group

Experimental group

Treatment:

Drug: Sugammadex

control group

Sham Comparator group

Treatment:

Drug: Saline