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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04608682

Collaborator

(none)

162

Enrollment

Location

Arms

18.5

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sugammadex Motor Evoked Potentials	Drug: Sugammadex Drug: Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 16, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing	China	100070

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruquan Han, Professor, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT04608682

Other Study ID Numbers:

WJP20201030

First Posted:

Oct 29, 2020

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 22, 2022