Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery
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
1 other identifier
interventional
90
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
July 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMay 15, 2012
May 1, 2012
8 months
June 28, 2011
May 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amplitude of MEP monitoring
the value of MEP amplitude every 30 min during MEP monitoring
every 30 min during MEP monitoring
Secondary Outcomes (4)
latency of MEP monitoring
every 30 min during MEP monitoring
Incidence of patient's spontaneous movement
from start to end of the MEP monitoring, an expected average of 4 hours
Overall assessment of MEP monitoring quality
from start to end of the MEP monitoring, an expected average of 4 hours
Incidence of patient's spontaneous respiration
from start to end of the MEP monitoring, an expected average of 4 hours
Study Arms (3)
TOF count guided group
ACTIVE COMPARATORadjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by No. of response to TOF stimulation
T1/T0 guided group
EXPERIMENTALadjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T1 twitch height as compared with control (T0)
T2/ T0 guided group
EXPERIMENTALadjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T2 twitch height as compared with baseline (T0)
Interventions
adjustment of vecuronium infusion dose every 15 minutes as guided by No. of response to TOF stimulation displayed by NMT module.
adjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module.
adjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module.
Eligibility Criteria
You may qualify if:
- Adult Patients undergoing neurosurgery with intraoperative motor evoked potential monitoring
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jeong Jin Lee
Seoul, 135-710, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Jin Lee, M.D.,Ph.D.
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Won Ho Kim, M.D.
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2011
First Posted
July 7, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 15, 2012
Record last verified: 2012-05