Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery
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ClinicalTrials.gov Identifier: NCT01388868 |
Recruitment Status
:
Completed
First Posted
: July 7, 2011
Last Update Posted
: May 15, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Surgery With Motor Evoked Potential Monitoring Spine Surgery With Motor Evoked Potential Monitoring | Other: TOF count guided adjustment Other: T1/ T0 guided adjustment Other: T2/ T0 guided adjustment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Official Title: | Determination of ED50 and ED95 of Vecuronium Infusion Dose for Maintaining Response of Train of Four Less Than 2 During the MEP Monitoring for Neurosurgery |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: TOF count guided group
adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by No. of response to TOF stimulation
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Other: 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.
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Experimental: 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)
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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.
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Experimental: 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)
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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.
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- Amplitude of MEP monitoring [ Time Frame: every 30 min during MEP monitoring ]the value of MEP amplitude every 30 min during MEP monitoring
- latency of MEP monitoring [ Time Frame: every 30 min during MEP monitoring ]latency of MEP monitoring every 30 min during MEP monitoring
- Incidence of patient's spontaneous movement [ Time Frame: from start to end of the MEP monitoring, an expected average of 4 hours ]Incidence of patient's spontaneous movement during MEP monitoring
- Overall assessment of MEP monitoring quality [ Time Frame: from start to end of the MEP monitoring, an expected average of 4 hours ]overall assessment of MEP monitoing quality provided by the electrophysiologist Grade I : no problem all through the monitoring Grade II : difficulty of monitoring for less than 5 min Grade III : difficulty of monitoring for 5 min to 30 min Grade IV : Difficulty of monitoring for more than 30 min
- Incidence of patient's spontaneous respiration [ Time Frame: from start to end of the MEP monitoring, an expected average of 4 hours ]Incidence of patient's spontaneous respiration as determined by end-tidal CO2 curve monitoring

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Ages Eligible for Study: | 20 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388868
Korea, Republic of | |
Jeong Jin Lee | |
Seoul, Korea, Republic of, 135-710 |
Principal Investigator: | Jeong Jin Lee, M.D.,Ph.D. | Samsung Medical Center | |
Principal Investigator: | Won Ho Kim, M.D. | Samsung Medical Center |
Responsible Party: | Jeong Jin Lee, Professor, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT01388868 History of Changes |
Other Study ID Numbers: |
2011-04-010 |
First Posted: | July 7, 2011 Key Record Dates |
Last Update Posted: | May 15, 2012 |
Last Verified: | May 2012 |
Keywords provided by Jeong Jin Lee, Samsung Medical Center:
infusion dose vecuronium motor evoked potential neuromuscular blocking agent |
Additional relevant MeSH terms:
Vecuronium Bromide Neuromuscular Blocking Agents Neuromuscular Nondepolarizing Agents Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Nicotinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |