Text Size

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
  Purpose

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).


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 90
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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.
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)
 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.
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)
 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.

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388868

Locations
Korea, Republic of
Jeong Jin Lee
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jeong Jin Lee, M.D.,Ph.D. Samsung Medical Center
Principal Investigator: Won Ho Kim, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jeong Jin Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01388868     History of Changes
Other Study ID Numbers: 2011-04-010
Study First Received: June 28, 2011
Last Updated: May 11, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
infusion dose
vecuronium
motor evoked potential
neuromuscular blocking agent

Additional relevant MeSH terms:
Neuromuscular Blocking Agents
Vecuronium Bromide
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Neuromuscular Nondepolarizing Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013