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Completed

NCT Number: NCT04608682

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

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.

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Key information

Conditions

Sugammadex Motor Evoked Potentials

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

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

Saline

Drug

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

Primary outcomes

  1. The success rate of TceMEPs

    Time frame: 5 minutes after first performing of TceMEPs

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

Secondary outcomes

  1. Mean value of amplitudes of TceMEPs

    Time frame: 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

  2. Mean value of latencies of TceMEPs

    Time frame: 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

  3. Thresholds of TceMEPs

    Time frame: 5 minutes after first performing of TceMEPs

    The thresholds that are required to obtain a dependable Transcranial motor evoked potentials monitoring（TceMEPs） response.

  4. respiratory pressure

    Time frame: during the surgery

    Peak respiratory pressures

  5. Adverse effects of sugammadex

    Time frame: 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

  6. Incidence of body movement

    Time frame: 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).

  7. Recurrence of neuromuscular blockade

    Time frame: time of extubation

    Recurrence of neuromuscular blockade defined as TOFr < 0.9

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2020
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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