Clinical Trial: Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Determination of Target of Adequate Partial Neuromuscular Blockade With Sevoflurane Anesthesia for Electrophysiologic Monitoring During Microvascular Decompression Surgery

Brief Summary: There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD. However, there have been no evidence of which degree of partial neuromuscular blockade should be performed during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.

Detailed Summary:

Hemifacial spasm develops by vascular compression of facial nerve at the root exit zone from brain stem. Microvascular decompression (MVD) is known for its curative treatment. Lateral spread response (LSR) is a kind of pathologic electromyographic (EMG) wave form which develops when facial nerve is compressed by vessel. There have been reports of monitoring LSR during MVD surgery helps predicting the clinical outcome of MVD.

As neuromuscular blockade during LSR monitoring decreases the amplitude of EMG, partial neuromuscular blockade is usually maintained during general anesthesia for MVD. However, there have been no evidence of which degree of partial neuromuscular blockade should be performed during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.


Sponsor: Samsung Medical Center

Current Primary Outcome:

  • Lateral spread response [ Time Frame: baseline (30 min after anesthetic induction) ]
    Lateral spread response of electromyography measured by electrophysiologist at baseline (30 min after anesthetic induction)
  • Lateral spread response [ Time Frame: before dura opening (45 minute after anesthetic induction) ]
    Lateral spread response of electromyography measured by electrophysiologist before dura opening
  • Lateral spread response [ Time Frame: after dura opening (60 min after anesthetic induction) ]
    Lateral spread response of electromyography measured by electrophysiologist after dura opening (one hour after anesthetic induction)
  • Lateral spread response [ Time Frame: before facial nerve decompression (90 minutes after anesthetic induction) ]
    Lateral spread response of electromyography measured by electrophysiologist before facial nerve decompression (90 minutes after anesthetic induction)
  • Lateral spread response [ Time Frame: after facial nerve decompression (120 min after anesthetic induction) ]
    Lateral spread response of electromyography measured by electrophysiologist after facial nerve decompression (2 hour after anesthetic induction)
  • Lateral spread response [ Time Frame: after dura closure (150 min after anesthetic induction) ]
    Lateral spread response of electromyography measured by electrophysiologist after dura closure

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Train-of-four response [ Time Frame: Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction) ]
      Train-of-four response to ulnar nerve electrical stimulation measured by NMT module at six time-points; Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction)
    • T1/Tc amplitude [ Time Frame: Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction) ]
      T1/Tc amplitude as a reponse to ulnar nerve stimulation measured by NMT module at six time points; Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction)
    • incidence of patients' spontaneous movements or respiration [ Time Frame: Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction) ]
      incidence of patients' spontaneous movements or respiration measured by anesthesiologists or reported by surgeon at six time points; Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction)
    • Mean blood pressure (mmHg) [ Time Frame: Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction) ]
      mean blood pressure measured by anesthesiologists at six time points; Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction)
    • heart rate (beats/min) [ Time Frame: Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction) ]
      heart rate measured by anesthesiologists at six time points; Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction)
    • pulse oximetry (oxygen saturation, %) [ Time Frame: Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction) ]
      pulse oximetry measured by anesthesiologists at six time points; Baseline (30min), Before dura open (45 min), After dura open (60 min), Before decompression (90 min), After decompression (120 min), After dura close (150 min after anesthetic induction)


    Original Secondary Outcome: Same as current

    Information By: Samsung Medical Center

    Dates:
    Date Received: June 5, 2012
    Date Started: June 2012
    Date Completion:
    Last Updated: December 24, 2013
    Last Verified: December 2013