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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01613781
Other study ID # 2012-05-051
Secondary ID
Status Completed
Phase N/A
First received June 5, 2012
Last updated December 24, 2013
Start date June 2012
Est. completion date February 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 during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial 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 during LSR monitoring under sevoflurane anesthesia. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of different degree of partial neuromuscular blockade on the LSR monitoring for MVD surgery.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Those who undergo microvascular decompression with sevoflurane anesthesia 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)


Intervention

Other:
TOF count-guided partial NMB
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)

Locations

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

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) No
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) No
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) No
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