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

Not Applicable

Completed

• Conditions: Sugammadex; Motor Evoked Potentials
• Interventions: Drug: Sugammadex; Drug: Saline

• Registration Number: NCT04608682
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-25
• Study First Submitted QC: 2020-10-25
• Study First Posted: 2020-10-29
• Study Start: 2021-08-16
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex group	Sugammadex	-
control group	Saline	-

Primary Outcome Measures

Name	Time	Method
The success rate of TceMEPs	5 minutes after first performing of TceMEPs	The success rate of Transcranial motor evoked potentials monitoring（TceMEPs）

Secondary Outcome Measures

Name	Time	Method
Adverse effects of sugammadex	during the surgery	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
Mean value of amplitudes of TceMEPs	5, 10, 20, 30 and 60 minutes after first performing of TceMEPs	Mean value of amplitudes of Transcranial motor evoked potentials monitoring（TceMEPs）in the abductor pollicis brevis muscles of both upper extremities
Incidence of body movement	during the surgery	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).
Recurrence of neuromuscular blockade	time of extubation	Recurrence of neuromuscular blockade defined as TOFr \< 0.9
Thresholds of TceMEPs	5 minutes after first performing of TceMEPs	The thresholds that are required to obtain a dependable Transcranial motor evoked potentials monitoring（TceMEPs） response.
respiratory pressure	during the surgery	Peak respiratory pressures
Mean value of latencies of TceMEPs	5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.	Mean value of latencies of Transcranial motor evoked potentials monitoring（TceMEPs） in the abductor pollicis brevis muscles of both upper extremities

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China