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

Hemifacial Spasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598961
• Other study ID #: 2012-03-089-001
• Status: Completed
• Phase: N/A
• First received: May 12, 2012
• Last updated: December 24, 2013
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Hemifacial Spasm
• Lateral Spread Response Monitoring
• Microvascular Decompression

Intervention

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)
• 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)
• No NMB
to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateral spread response	Lateral spread response of electromyography measured by electrophysiologist at baseline (30 min after anesthetic induction)	baseline (30 min after anesthetic induction)	No
Primary	Lateral spread response	Lateral spread response of electromyography measured by electrophysiologist before dura opening	before dura opening (45 minute after anesthetic induction)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Train-of-four response	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)	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)	No
Secondary	T1/Tc amplitude	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)	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)	No
Secondary	incidence of patients' spontaneous movements or respiration	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)	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)	No
Secondary	Mean blood pressure (mmHg)	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)	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)	Yes
Secondary	heart rate (beats/min)	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)	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)	Yes
Secondary	pulse oximetry (oxygen saturation, %)	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)	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)	Yes