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

NCT01598961 | Completed DMC

• 1 other identifier: 2012-03-089-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hemifacial Spasm; Microvascular Decompression; Lateral Spread Response Monitoring

Outcome Measures

Primary Outcomes (6)

• Lateral spread response

  Lateral spread response of electromyography measured by electrophysiologist at baseline (30 min after anesthetic induction)

  baseline (30 min after anesthetic induction)

• Lateral spread response

  Lateral spread response of electromyography measured by electrophysiologist before dura opening

  before dura opening (45 minute after anesthetic induction)

• Lateral spread response

  Lateral spread response of electromyography measured by electrophysiologist after dura opening (one hour after anesthetic induction)

  after dura opening (60 min after anesthetic induction)

• Lateral spread response

  Lateral spread response of electromyography measured by electrophysiologist before facial nerve decompression (90 minutes after anesthetic induction)

  before facial nerve decompression (90 minutes after anesthetic induction)

• Lateral spread response

  Lateral spread response of electromyography measured by electrophysiologist after facial nerve decompression (2 hour after anesthetic induction)

  after facial nerve decompression (120 min after anesthetic induction)

• Lateral spread response

  Lateral spread response of electromyography measured by electrophysiologist after dura closure (150 min after anesthetic induction)

  after dura closure (150 min after anesthetic induction)

Secondary Outcomes (6)

• Train-of-four response

  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

  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

  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)

  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)

  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)

Study Arms (3)

TOF count-guided group

ACTIVE COMPARATOR

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

T1/Tc amplitude group

ACTIVE COMPARATOR

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

No neuromuscular blockade group

EXPERIMENTAL

to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction

Other: No NMB

Interventions

TOF count-guided partial NMB OTHER

Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module)

TOF count-guided group

T1/Tc guided partial NMB OTHER

Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)

T1/Tc amplitude group

No NMB OTHER

to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction

No neuromuscular blockade group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-Gu, 135-710, South Korea

Location

MeSH Terms

Conditions

Hemifacial Spasm

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeong Jin Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Won Ho Kim, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

KR (1)