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

NCT04471376 | Completed

• 1 other identifier: WJP20200708
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sugammadex

Outcome Measures

Primary Outcomes (1)

• The amplitude of MEP

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

  5 minutes after dura opening

Secondary Outcomes (8)

• The amplitude of MEP

  10, 20, 30 and 60 minutes after dura opening

• The latencies of MEPs

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

• Respiratory parameters

  during the surgery

• Adverse effects of sugammadex

  during and 24 hours after the surgery

• Incidence of body movement

  during the surgery

Study Arms (2)

Sugammadex group

ACTIVE COMPARATOR

Drug: Sugammadex

control group

NO INTERVENTION

Interventions

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

Also known as: Bridion

Sugammadex 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:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Ruquan Han, M.D., Ph.D

  Department of Anesthesiology, Beijing Tiantan Hospital

  STUDY CHAIR

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: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: July 16, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following 5 years article publication
• Access Criteria: Proposals should be directed to ruquan.han@ccmu.edu.cn. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)