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

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

Study Overview

• Status: Completed
• Conditions: Sugammadex
• Intervention / Treatment: Drug: Sugammadex

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group
ACTIVE_COMPARATOR: Sugammadex group	Drug: Sugammadex; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amplitude of MEP	Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening.	10, 20, 30 and 60 minutes after dura opening
The latencies of MEPs	Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities	5, 10, 20, 30 and 60 minutes after dura opening.
Respiratory parameters	Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O.	during the surgery
Adverse effects of sugammadex	Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc.	during and 24 hours after the surgery
Incidence of body movement	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).	during the surgery
Recurrence of neuromuscular blockade	Recurrence of neuromuscular blockade at the end of surgery.	At the end of surgery
Motor function assessment	SMP-a scale	5 days after surgery
Total bleeding volume	Total bleeding volume during the surgery	during the surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (ACTUAL): July 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: WJP20200708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, statistical analysis plan and informed consent form will be shared beginning 3 months and ending 5 years following 5 years article publication.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following 5 years article publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No