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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sugammadex

Intervention / Treatment
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* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sugammadex group<br> | Drug: Sugammadex<br>* 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<br>* Other names: Bridion;|
| No Intervention: control group<br> | |

What is the study measuring?
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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 |