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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong Jin Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01388868
First received: June 28, 2011
Last updated: May 11, 2012
Last verified: May 2012
History of Changes

June 28, 2011
May 11, 2012
June 2011
February 2012   (final data collection date for primary outcome measure)
Amplitude of MEP monitoring [ Time Frame: every 30 min during MEP monitoring ] [ Designated as safety issue: Yes ]
the value of MEP amplitude every 30 min during MEP monitoring
Same as current
Complete list of historical versions of study NCT01388868 on ClinicalTrials.gov Archive Site
  • latency of MEP monitoring [ Time Frame: every 30 min during MEP monitoring ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Incidence of patient's spontaneous respiration as determined by end-tidal CO2 curve monitoring
Same as current
Not Provided
Not Provided
 
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

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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Brain Surgery With Motor Evoked Potential Monitoring
  • Spine Surgery With Motor Evoked Potential Monitoring
  • 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.
  • 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.
  • 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.
  • 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
    Intervention: Other: TOF count guided adjustment
  • 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)
    Intervention: Other: T1/ T0 guided adjustment
  • 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)
    Intervention: Other: T2/ T0 guided adjustment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2012
February 2012   (final data collection date for primary outcome measure)

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)
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01388868
2011-04-010
No
Jeong Jin Lee, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Jeong Jin Lee, M.D.,Ph.D. Samsung Medical Center
Principal Investigator: Won Ho Kim, M.D. Samsung Medical Center
Samsung Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP