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

NCT ID: NCT01690364

Last Updated: 2013-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-03-31

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.

Conditions

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

Keywords

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Motor evoked potential monitoring General Anesthesia Neurosurgery Cisatracurium Vecuronium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cisatracurium Group

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Group Type EXPERIMENTAL

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Intervention Type OTHER

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Vecuronium Group

MEP monitoring with continuous infusion of vecuronium during general anesthesia

Group Type ACTIVE_COMPARATOR

MEP monitoring with continuous infusion of vecuronium during general anesthesia

Intervention Type OTHER

MEP monitoring with continuous infusion of vecuronium during general anesthesia

Interventions

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MEP monitoring with continuous infusion of vecuronium during general anesthesia

MEP monitoring with continuous infusion of vecuronium during general anesthesia

Intervention Type OTHER

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Intervention Type OTHER

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Jin Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-05-090-001

Identifier Type: -

Identifier Source: org_study_id