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

NCT04608682 | Completed

• 1 other identifier: WJP20201030
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Sugammadex; Motor Evoked Potentials

Outcome Measures

Primary Outcomes (1)

• The success rate of TceMEPs

  The success rate of Transcranial motor evoked potentials monitoring（TceMEPs）

  5 minutes after first performing of TceMEPs

Secondary Outcomes (7)

• Mean value of amplitudes of TceMEPs

  5, 10, 20, 30 and 60 minutes after first performing of TceMEPs

• Mean value of latencies of TceMEPs

  5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.

• Thresholds of TceMEPs

  5 minutes after first performing of TceMEPs

• respiratory pressure

  during the surgery

• Adverse effects of sugammadex

  during the surgery

Study Arms (2)

Sugammadex group

EXPERIMENTAL

Drug: Sugammadex

control group

SHAM COMPARATOR

Drug: Saline

Interventions

Sugammadex DRUG

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

Sugammadex group

Saline DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical status I to II

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (2)

• 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.

  PMID: 37626303 DERIVED

• 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.

  PMID: 35501072 DERIVED

MeSH Terms

Interventions

Sugammadex; Sodium Chloride

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: October 29, 2020
• Study Start: August 16, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months after the study is finished
• Access Criteria: principal investigator

Locations

CN (1)