Effect of Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording

Sugammadex Clinical Trial

Official title:

Effect of Intraoperative Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608682
• Other study ID #: WJP20201030
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• 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 surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age range from 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical status I to II

Exclusion Criteria:

• BMI =35 kg/m-2
• History of epilepsy or use of antiepileptic drugs
• Personal history or family history of malignant hyperthermia
• Allergies to sugammadex; NMBs or other medication(s) used during general anesthesia
• Hemoglobin <110 g/L
• TceMEP stimulation or recorded site infection
• Preoperative neurological dysfunction in both upper extremities
• Cardiac pacemaker
• Pregnancy and lactation

Related Conditions & MeSH terms

• Motor Evoked Potentials
• Sugammadex

Intervention

Drug:
• Sugammadex
The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.
• Saline
The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	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 success rate of TceMEPs	The success rate of Transcranial motor evoked potentials monitoring(TceMEPs)	5 minutes after first performing of TceMEPs
Secondary	Mean value of amplitudes of TceMEPs	Mean value of amplitudes of Transcranial motor evoked potentials monitoring(TceMEPs)in the abductor pollicis brevis muscles of both upper extremities	5, 10, 20, 30 and 60 minutes after first performing of TceMEPs
Secondary	Mean value of latencies of TceMEPs	Mean value of latencies of Transcranial motor evoked potentials monitoring(TceMEPs) in the abductor pollicis brevis muscles of both upper extremities	5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.
Secondary	Thresholds of TceMEPs	The thresholds that are required to obtain a dependable Transcranial motor evoked potentials monitoring(TceMEPs) response.	5 minutes after first performing of TceMEPs
Secondary	respiratory pressure	Peak respiratory pressures	during the surgery
Secondary	Adverse effects of sugammadex	Adverse effects of sugammadex such as anaphylaxis (including flushing, oedema, tachycardia and bronchospasm), arrhythmias (heart rate lower than 60bpm), postprocedural pain, nausea and vomiting, fever (body temperature more than 37.3? ), and diarrhea, etc	during the surgery
Secondary	Incidence of body movement	Incidence of body movement classified as 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 anaesthesia teams).	during the surgery
Secondary	Recurrence of neuromuscular blockade	Recurrence of neuromuscular blockade defined as TOFr < 0.9	time of extubation