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

Not Applicable

Completed

• Conditions: General Anesthesia; Spine Tumor; Neurosurgery; Cerebral Aneurysm; Motor Evoked Potential Monitoring; Brain Tumor
• Interventions: Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia; Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia

• Registration Number: NCT01690364
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Adult patients undergoing neurosurgery with intraoperative motor evoked potential monitoring

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisatracurium Group	MEP monitoring with continuous infusion of cisatracurium during general anesthesia	MEP monitoring with continuous infusion of cisatracurium during general anesthesia
Vecuronium Group	MEP monitoring with continuous infusion of vecuronium during general anesthesia	MEP monitoring with continuous infusion of vecuronium during general anesthesia

Primary Outcome Measures

Name	Time	Method
MEP amplitude	300 min after anesthetic induction	intraoperative motor evoked potential monitoring amplitude

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of