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

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Capital Medical University

Status

Completed

Conditions

Sugammadex

Treatments

Drug: Sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT04471376
WJP20200708

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

Sugammadex group
Active Comparator group
Treatment:
Drug: Sugammadex
control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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