Hemifacial SpasmNCT01598961
Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
A study testing TOF count-guided partial NMB, T1/Tc guided partial NMB and No NMB in people with Hemifacial Spasm and Microvascular Decompression, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hemifacial Spasm, Microvascular Decompression, Lateral Spread Response Monitoring
- What is being tested?
- TOF count-guided partial NMB, T1/Tc guided partial NMB and No NMB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who undergo microvascular decompression by diagnosis of hemifacial spasm in our institution
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- TOF count-guided partial NMB, T1/Tc guided partial NMB, No NMB
- Medical subject headings
- Hemifacial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF count-guided partial NMBOther
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 NMBOther
Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)
No NMBOther
to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| TOF count-guided group | Active comparator | Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module) Receives: Other: TOF count-guided partial NMB |
| T1/Tc amplitude group | Active comparator | Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT) Receives: Other: T1/Tc guided partial NMB |
| No neuromuscular blockade group | Experimental | to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction Receives: Other: No NMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral spread response
Lateral spread response of electromyography measured by electrophysiologist at baseline (30 min after anesthetic induction)
Measured: baseline (30 min after anesthetic induction)
Lateral spread response
Lateral spread response of electromyography measured by electrophysiologist before dura opening
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: after dura closure (150 min after anesthetic induction)
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial SpasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Jin Lee, Samsung Medical Center
- Investigators
- Jeong Jin Lee, MD, PhD, Principal investigator, Samsung Medical CenterWon Ho Kim, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598961
- Sponsor's protocol ID
- 2012-03-089-001
- Status last verified
- Dec 2013
- First submitted
- 12 May 2012
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery
- ClinicalTrials.gov ID
- NCT01598961
- Acronym / sponsor ID
- 2012-03-089-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TOF count-guided group | Active comparator | Other: TOF count-guided partial NMBUsing partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module) |
| T1/Tc amplitude group | Active comparator | Other: T1/Tc guided partial NMBUsing partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT) |
| No neuromuscular blockade group | Experimental | Other: No NMBto maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who undergo microvascular decompression by diagnosis of hemifacial spasm in our institution
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOF count-guided partial NMBUsing 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 group |
| T1/Tc guided partial NMBUsing partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT) | Other | T1/Tc amplitude group |
| No NMBto maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction | Other | No neuromuscular blockade group |
Primary outcome
Lateral spread response
Time frame: baseline (30 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist at baseline (30 min after anesthetic induction)
Lateral spread response
Time frame: before dura opening (45 minute after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist before dura opening
Lateral spread response
Time frame: after dura opening (60 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist after dura opening (one hour after anesthetic induction)
Lateral spread response
Time frame: before facial nerve decompression (90 minutes after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist before facial nerve decompression (90 minutes after anesthetic induction)
Lateral spread response
Time frame: after facial nerve decompression (120 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist after facial nerve decompression (2 hour after anesthetic induction)
Lateral spread response
Time frame: after dura closure (150 min after anesthetic induction)
Lateral spread response of electromyography measured by electrophysiologist after dura closure (150 min after anesthetic induction)
6 secondary outcomes
Train-of-four response
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
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
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)
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)
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, %)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Jin Lee, MD, PhD principal investigator
Samsung Medical Center
Won Ho Kim, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOF count-guided partial NMB, T1/Tc guided partial NMB and No NMB in people with Hemifacial Spasm and Microvascular Decompression, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral spread response (time frame: baseline (30 min after anesthetic induction)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2013.