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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01388868
Enrollment
90
Registered
2011-07-07
Start date
2011-06-30
Completion date
2012-02-29
Last updated
2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

infusion dose, vecuronium, motor evoked potential, neuromuscular blocking agent

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).

Detailed description

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.

Interventions

OTHERTOF count guided adjustment

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

OTHERT1/ 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.

OTHERT2/ 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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Amplitude of MEP monitoringevery 30 min during MEP monitoringthe value of MEP amplitude every 30 min during MEP monitoring

Secondary

MeasureTime frameDescription
latency of MEP monitoringevery 30 min during MEP monitoringlatency of MEP monitoring every 30 min during MEP monitoring
Incidence of patient's spontaneous movementfrom start to end of the MEP monitoring, an expected average of 4 hoursIncidence of patient's spontaneous movement during MEP monitoring
Overall assessment of MEP monitoring qualityfrom start to end of the MEP monitoring, an expected average of 4 hoursoverall 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 respirationfrom start to end of the MEP monitoring, an expected average of 4 hoursIncidence of patient's spontaneous respiration as determined by end-tidal CO2 curve monitoring

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026