Clinical trial NCT01598961: Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
Official title: Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemifacial Spasm
Microvascular Decompression
Lateral Spread Response Monitoring
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Lateral spread response
timeFrame: baseline (30 min after anesthetic induction)
measure: Lateral spread response
timeFrame: before dura opening (45 minute after anesthetic induction)
measure: Lateral spread response
timeFrame: after dura opening (60 min after anesthetic induction)
measure: Lateral spread response
timeFrame: before facial nerve decompression (90 minutes after anesthetic induction)
measure: Lateral spread response
timeFrame: after facial nerve decompression (120 min after anesthetic induction)
measure: Lateral spread response
timeFrame: after dura closure (150 min after anesthetic induction)
Secondary outcomes:
measure: Train-of-four response
timeFrame: 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)
measure: T1/Tc amplitude
timeFrame: 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)
measure: incidence of patients' spontaneous movements or respiration
timeFrame: 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)
measure: Mean blood pressure (mmHg)
timeFrame: 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)
measure: heart rate (beats/min)
timeFrame: 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)
measure: pulse oximetry (oxygen saturation, %)
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-Gu
Study officials:
affiliation: Samsung Medical Center
name: Jeong Jin Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: