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

Sugammadex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471376
• Other study ID #: WJP20200708
• Status: Completed
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sugammadex

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	Respiratory parameters	Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O.	during the surgery
Secondary	Adverse effects of sugammadex	Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc.	during and 24 hours after the surgery
Secondary	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
Secondary	Recurrence of neuromuscular blockade	Recurrence of neuromuscular blockade at the end of surgery.	At the end of surgery
Secondary	Motor function assessment	SMP-a scale	5 days after surgery
Secondary	Total bleeding volume	Total bleeding volume during the surgery	during the surgery