Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery

NCT ID: NCT01388868

Last Updated: 2012-05-15

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).

Detailed Description

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The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland). Previously, one to two counts of response to TOF stimulation has been considered to be primary goal of partial neuromuscular blocking needed for intraoperative motor evoked potential monitoring. However, the visualization of twitch height of response to TOF stimulation has been possible with the help of NMT module. For adequate motor evoked potential monitoring, twitch height of T1 or T2 is also as important as simple count of TOF stimulation. The investigators tried to establish a vecuronium infusion strategy as guided by not only count of TOF stimulation but also twitch height of T1 or T2.

Conditions

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Brain Surgery With Motor Evoked Potential Monitoring Spine Surgery With Motor Evoked Potential Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TOF count guided group

adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by No. of response to TOF stimulation

Group Type ACTIVE_COMPARATOR

TOF count guided adjustment

Intervention Type OTHER

adjustment of vecuronium infusion dose every 15 minutes as guided by No. of response to TOF stimulation displayed by NMT module.

T1/T0 guided group

adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T1 twitch height as compared with control (T0)

Group Type EXPERIMENTAL

T1/ T0 guided adjustment

Intervention Type OTHER

adjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module.

T2/ T0 guided group

adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T2 twitch height as compared with baseline (T0)

Group Type EXPERIMENTAL

T2/ T0 guided adjustment

Intervention Type OTHER

adjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module.

Interventions

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TOF count guided adjustment

adjustment of vecuronium infusion dose every 15 minutes as guided by No. of response to TOF stimulation displayed by NMT module.

Intervention Type OTHER

T1/ T0 guided adjustment

adjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module.

Intervention Type OTHER

T2/ T0 guided adjustment

adjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module.

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

70 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

Principal Investigators

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Jeong Jin Lee, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Won Ho Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Jeong Jin Lee

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2011-04-010

Identifier Type: -

Identifier Source: org_study_id

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