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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong Jin Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01598961
First received: May 12, 2012
Last updated: December 24, 2013
Last verified: December 2013

May 12, 2012
December 24, 2013
May 2012
April 2013   (final data collection date for primary outcome measure)
  • Lateral spread response [ Time Frame: baseline (30 min after anesthetic induction) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Lateral spread response of electromyography measured by electrophysiologist before dura opening
  • Lateral spread response [ Time Frame: after dura opening (60 min after anesthetic induction) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Lateral spread response of electromyography measured by electrophysiologist after dura closure (150 min after anesthetic induction)
Same as current
Complete list of historical versions of study NCT01598961 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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)
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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)
  • hemodynamic parameters [ 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) ] [ Designated as safety issue: Yes ]
    hemodynamic parameters (blood pressure, heart rate, 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)
Not Provided
Not Provided
 
Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery

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 or no neuromuscular blockade could be performed during LSR monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the LSR monitoring for MVD surgery.

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 or no neuromuscular blockade could be performed during LSR monitoring. Therefore, we performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade, including no neuromuscular blockade on the LSR monitoring for MVD surgery.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Hemifacial Spasm
  • Microvascular Decompression
  • Lateral Spread Response Monitoring
  • Other: TOF count-guided partial NMB
    Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module)
  • Other: T1/Tc guided partial NMB
    Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)
  • Other: No NMB
    to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction
  • Active Comparator: TOF count-guided group
    Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module)
    Intervention: Other: TOF count-guided partial NMB
  • Active Comparator: T1/Tc amplitude group
    Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)
    Intervention: Other: T1/Tc guided partial NMB
  • Experimental: No neuromuscular blockade group
    to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction
    Intervention: Other: No NMB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Those who undergo microvascular decompression by diagnosis of hemifacial spasm in our institution

Exclusion Criteria:

  • Patients were excluded from the study if they had any of following: severe cardiopulmonary disorder with hemodynamic unstability (pulmonary hypertension, cardiomyopathy, mechanical ventilation, American Society of Anesthesiologists physical status III or more), severe hepatic or renal disease.
  • Those who can not undergo MEP monitoring due to central or peripheral neuromuscular disease, e.g. cerebral palsy, myasthenia gravis, acute spinal injury, neurologic shock
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01598961
2012-03-089-001
Yes
Jeong Jin Lee, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Jeong Jin Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD Samsung Medical Center
Samsung Medical Center
December 2013

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