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

NCT ID: NCT04608682

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2022-08-30

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.

Detailed Description

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Conditions

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Sugammadex Motor Evoked Potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sugammadex group

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.

control group

Group Type SHAM_COMPARATOR

Saline

Intervention Type DRUG

The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.

Interventions

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Sugammadex

The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.

Intervention Type DRUG

Saline

The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ruquan Han

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Jian M, Liu H, Liang F, Ma B, Wang L, Zhou Y, Qiao H, Han R, Wang C. Effect of intraoperative muscle relaxation reversal on the success rate of motor evoked potential recording in patients undergoing spinal surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Aug 25;23(1):290. doi: 10.1186/s12871-023-02211-z.

Reference Type DERIVED
PMID: 37626303 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35501072 (View on PubMed)

Other Identifiers

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WJP20201030

Identifier Type: -

Identifier Source: org_study_id

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