An interventional study of TOF count-guided partial NMB and T1/Tc guided partial NMB in Hemifacial Spasm, Microvascular Decompression and Neuromuscular Blockade, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-12-25.
Sponsored by Samsung Medical Center · Not applicable and Interventional
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.
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.
23 studies on the registry are indexed under Hemifacial Spasm; 3 are open to participants now.
This study's enrollment of 61 is close to the median of 61 across 11 interventional studies indexed under Hemifacial Spasm.
Browse Hemifacial Spasm studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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)
Also known as: 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)
Also known as: neuromuscular transmission module (NMT)
Lateral spread response
Lateral spread response of electromyography measured by electrophysiologist at baseline (30 min after anesthetic induction)
Time frame: baseline (30 min after anesthetic induction)
Lateral spread response
Lateral spread response of electromyography measured by electrophysiologist before dura opening
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: after dura closure (150 min after anesthetic induction)
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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)
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)
Time frame: 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)
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)
Time frame: 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, %)
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)
Time frame: 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)
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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