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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01598961
Enrollment
150
Registered
2012-05-15
Start date
2012-05-31
Completion date
2013-04-30
Last updated
2013-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemifacial Spasm, Lateral Spread Response Monitoring, Microvascular Decompression

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.

Interventions

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

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

OTHERNo NMB

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
T1/Tc amplitudeBaseline (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 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 respirationBaseline (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 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)
Train-of-four responseBaseline (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 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)
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)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, %)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 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)
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)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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026