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NCT Number: NCT04471376

The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery

Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.

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Key information

Conditions

Sugammadex

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-65 years
  • ASA status I-II
  • Patients undergo thoracic or lumbar spinal surgery
  • tcMEP monitoring during the surgery
  • Informed consent signed by patients

Exclusion criteria

  • BMI ≥35 Kg/m-2
  • history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)
  • history or family history of malignant hyperthermia
  • allergies to sugammadex, NMBs or other medication(s) used during general anesthesia
  • anemia, hemoglobin <110g/L,
  • TcMEPs stimulate or record site infection
  • preoperative neurological dysfunction in both upper extremities
  • cardiac pacemaker
  • pregnancy and breast-feeding

Treatment and study plan

Sugammadex

Drug

Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP

Other names: Bridion

Primary outcomes

  1. The amplitude of MEP

    Time frame: 5 minutes after dura opening

    mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities

Secondary outcomes

  1. The amplitude of MEP

    Time frame: 10, 20, 30 and 60 minutes after dura opening

    Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening.

  2. The latencies of MEPs

    Time frame: 5, 10, 20, 30 and 60 minutes after dura opening.

    Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities

  3. Respiratory parameters

    Time frame: during the surgery

    Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O.

  4. Adverse effects of sugammadex

    Time frame: during and 24 hours after the surgery

    Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc.

  5. Incidence of body movement

    Time frame: during the surgery

    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 anesthesia teams).

  6. Recurrence of neuromuscular blockade

    Time frame: At the end of surgery

    Recurrence of neuromuscular blockade at the end of surgery.

  7. Motor function assessment

    Time frame: 5 days after surgery

    SMP-a scale

  8. Total bleeding volume

    Time frame: during the surgery

    Total bleeding volume during the surgery

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2020
Registry last updated
Apr 6, 2021

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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