Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery

Study Overview
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Brief Summary
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Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery. As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.

Detailed Description
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Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery. As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.

Official Title
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Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery

Conditions
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Motor Evoked Potential Monitoring, General Anesthesia, Neurosurgery, Brain Tumor, Spine Tumor, Cerebral Aneurysm

Intervention / Treatment
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* Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia
* Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing neurosurgery with intraoperative motor evoked potential monitoring Exclusion Criteria: Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock) Patients with hepatic or renal disease with altered metabolism of vecuronium Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisatracurium Group<br>MEP monitoring with continuous infusion of cisatracurium during general anesthesia | Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia<br>* MEP monitoring with continuous infusion of cisatracurium during general anesthesia<br>|
| Active Comparator: Vecuronium Group<br>MEP monitoring with continuous infusion of vecuronium during general anesthesia | Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia<br>* MEP monitoring with continuous infusion of vecuronium during general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 15 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 30 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 45 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 60 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 75 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 90 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 105 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 120 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 135 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 150 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 165 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 180 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 195 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 210 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 225 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 240 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 255 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 270 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 285 min after anesthetic induction | 
| MEP amplitude | intraoperative motor evoked potential monitoring amplitude | 300 min after anesthetic induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of variation (CV) of MEP amplitude | Coefficient of variation (CV) of intraoperative motor evoked potential monitoring amplitude | at the end of the surgery (5H after the start of surgery) | 
| Average of MEP amplitudes | Average of all measured MEP amplitudes in a subject | at the end of the surgery (5H after the start of surgery) | 
| The frequency of adjusting the infusion dose of muscle relaxant | The frequency of adjusting the infusion dose of muscle relaxant | at the end of the surgery (5H after the start of surgery) | 
| Average of Latency of MEP amplitude | Average of Latency of MEP amplitude | at the end of the surgery (5H after the start of surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor evoked potential monitoring, General Anesthesia, Neurosurgery, Cisatracurium, Vecuronium