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Completed

NCT Number: NCT01690364

Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery

Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.

As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.

Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.

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Key information

About this study

Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.

As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.

Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.

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

MEP monitoring with continuous infusion of vecuronium during general anesthesia

Other

MEP monitoring with continuous infusion of vecuronium during general anesthesia

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Other

MEP monitoring with continuous infusion of cisatracurium during general anesthesia

Primary outcomes

  1. MEP amplitude

    Time frame: 15 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  2. MEP amplitude

    Time frame: 30 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  3. MEP amplitude

    Time frame: 45 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  4. MEP amplitude

    Time frame: 60 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  5. MEP amplitude

    Time frame: 75 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  6. MEP amplitude

    Time frame: 90 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  7. MEP amplitude

    Time frame: 105 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  8. MEP amplitude

    Time frame: 120 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  9. MEP amplitude

    Time frame: 135 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  10. MEP amplitude

    Time frame: 150 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  11. MEP amplitude

    Time frame: 165 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  12. MEP amplitude

    Time frame: 180 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  13. MEP amplitude

    Time frame: 195 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  14. MEP amplitude

    Time frame: 210 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  15. MEP amplitude

    Time frame: 225 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  16. MEP amplitude

    Time frame: 240 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  17. MEP amplitude

    Time frame: 255 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  18. MEP amplitude

    Time frame: 270 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  19. MEP amplitude

    Time frame: 285 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

  20. MEP amplitude

    Time frame: 300 min after anesthetic induction

    intraoperative motor evoked potential monitoring amplitude

Secondary outcomes

  1. Coefficient of variation (CV) of MEP amplitude

    Time frame: at the end of the surgery (5H after the start of surgery)

    Coefficient of variation (CV) of intraoperative motor evoked potential monitoring amplitude

  2. Average of MEP amplitudes

    Time frame: at the end of the surgery (5H after the start of surgery)

    Average of all measured MEP amplitudes in a subject

  3. The frequency of adjusting the infusion dose of muscle relaxant

    Time frame: at the end of the surgery (5H after the start of surgery)

    The frequency of adjusting the infusion dose of muscle relaxant

  4. Average of Latency of MEP amplitude

    Time frame: at the end of the surgery (5H after the start of surgery)

    Average of Latency of MEP amplitude

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2012
Registry last updated
Dec 25, 2013

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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