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Completed

NCT Number: NCT01388868

Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During 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).

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeong Jin Lee

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TOF count guided adjustment

Other

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

T1/ T0 guided adjustment

Other

adjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module.

T2/ T0 guided adjustment

Other

adjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module.

Primary outcomes

  1. Amplitude of MEP monitoring

    Time frame: every 30 min during MEP monitoring

    the value of MEP amplitude every 30 min during MEP monitoring

Secondary outcomes

  1. latency of MEP monitoring

    Time frame: every 30 min during MEP monitoring

    latency of MEP monitoring every 30 min during MEP monitoring

  2. Incidence of patient's spontaneous movement

    Time frame: from start to end of the MEP monitoring, an expected average of 4 hours

    Incidence of patient's spontaneous movement during MEP monitoring

  3. Overall assessment of MEP monitoring quality

    Time frame: from start to end of the MEP monitoring, an expected average of 4 hours

    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

  4. Incidence of patient's spontaneous respiration

    Time frame: from start to end of the MEP monitoring, an expected average of 4 hours

    Incidence of patient's spontaneous respiration as determined by end-tidal CO2 curve monitoring

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 7, 2011
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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