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
  Purpose

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.


Condition Intervention
Hemifacial Spasm
Microvascular Decompression
Lateral Spread Response Monitoring
Other: TOF count-guided partial NMB
Other: T1/Tc guided partial NMB
Other: No NMB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 150
Study Start Date: May 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
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)
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)
Experimental: No neuromuscular blockade group
to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction
Other: No NMB
to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598961

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Gangnam-Gu, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jeong Jin Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jeong Jin Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01598961     History of Changes
Other Study ID Numbers: 2012-03-089-001
Study First Received: May 12, 2012
Last Updated: December 24, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hemifacial Spasm
Mouth Diseases
Stomatognathic Diseases
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014