Clinical trial NCT01388868: Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Amplitude of MEP monitoring
timeFrame: every 30 min during MEP monitoring
Secondary outcomes:
measure: latency of MEP monitoring
timeFrame: every 30 min during MEP monitoring
measure: Incidence of patient's spontaneous movement
timeFrame: from start to end of the MEP monitoring, an expected average of 4 hours
measure: Overall assessment of MEP monitoring quality
timeFrame: from start to end of the MEP monitoring, an expected average of 4 hours
measure: Incidence of patient's spontaneous respiration
timeFrame: from start to end of the MEP monitoring, an expected average of 4 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jeong Jin Lee
Study officials:
affiliation: Samsung Medical Center
name: Jeong Jin Lee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: