Brain Surgery With Motor Evoked Potential MonitoringNCT01388868
Strategy for Maintaining Partial Neuromuscular Blocking Adequate for Motor Evoked Potential During Neurosurgery
A study testing TOF count guided adjustment, T1/ T0 guided adjustment and T2/ T0 guided adjustment in people with Brain Surgery With Motor Evoked Potential Monitoring and Spine Surgery With Motor Evoked Potential Monitoring, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Brain Surgery With Motor Evoked Potential Monitoring, Spine Surgery With Motor Evoked Potential Monitoring
- What is being tested?
- TOF count guided adjustment, T1/ T0 guided adjustment and T2/ T0 guided adjustment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Feb 2012
- 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
- Adult Patients undergoing neurosurgery with intraoperative motor evoked potential monitoring
Who cannot join
- Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock)
- Patients with hepatic or renal disease with altered metabolism of vecuronium
- Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of ED50 and ED95 of Vecuronium Infusion Dose for Maintaining Response of Train of Four Less Than 2 During the MEP Monitoring for Neurosurgery
The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).
Read the detailed description
The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland). Previously, one to two counts of response to TOF stimulation has been considered to be primary goal of partial neuromuscular blocking needed for intraoperative motor evoked potential monitoring. However, the visualization of twitch height of response to TOF stimulation has been possible with the help of NMT module. For adequate motor evoked potential monitoring, twitch height of T1 or T2 is also as important as simple count of TOF stimulation. The investigators tried to establish a vecuronium infusion strategy as guided by not only count of TOF stimulation but also twitch height of T1 or T2.
- Conditions
- Brain Surgery With Motor Evoked Potential Monitoring, Spine Surgery With Motor Evoked Potential Monitoring
- Being tested
- TOF count guided adjustment, T1/ T0 guided adjustment, T2/ T0 guided adjustment
- Keywords
- infusion dose, vecuronium, motor evoked potential, neuromuscular blocking agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF count guided adjustmentOther
adjustment of vecuronium infusion dose every 15 minutes as guided by No. of response to TOF stimulation displayed by NMT module.
T1/ T0 guided adjustmentOther
adjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module.
T2/ T0 guided adjustmentOther
adjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module.
| Study group | Role | What they receive |
|---|---|---|
| TOF count guided group | Active comparator | adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by No. of response to TOF stimulation Receives: Other: TOF count guided adjustment |
| T1/T0 guided group | Experimental | adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T1 twitch height as compared with control (T0) Receives: Other: T1/ T0 guided adjustment |
| T2/ T0 guided group | Experimental | adjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T2 twitch height as compared with baseline (T0) Receives: Other: T2/ T0 guided adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of MEP monitoring
the value of MEP amplitude every 30 min during MEP monitoring
Measured: every 30 min during MEP monitoring
Secondary outcomes (4)
latency of MEP monitoring
latency of MEP monitoring every 30 min during MEP monitoring
Measured: every 30 min during MEP monitoring
Incidence of patient's spontaneous movement
Incidence of patient's spontaneous movement during MEP monitoring
Measured: from start to end of the MEP monitoring, an expected average of 4 hours
Overall assessment of MEP monitoring quality
overall assessment of MEP monitoing quality provided by the electrophysiologist Grade I : no problem all through the monitoring Grade II : difficulty of monitoring for less than 5 min Grade III : difficulty of monitoring for 5 min to 30 min Grade IV : Difficulty of monitoring for more than 30 min
Measured: from start to end of the MEP monitoring, an expected average of 4 hours
Incidence of patient's spontaneous respiration
Incidence of patient's spontaneous respiration as determined by end-tidal CO2 curve monitoring
Measured: from start to end of the MEP monitoring, an expected average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Surgery With Motor Evoked Potential MonitoringStudies 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
- 90 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, M.D.,Ph.D., Principal investigator, Samsung Medical CenterWon Ho Kim, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388868
- Sponsor's protocol ID
- 2011-04-010
- Status last verified
- May 2012
- First submitted
- 28 Jun 2011
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of ED50 and ED95 of Vecuronium Infusion Dose for Maintaining Response of Train of Four Less Than 2 During the MEP Monitoring for Neurosurgery
- ClinicalTrials.gov ID
- NCT01388868
- Acronym / sponsor ID
- 2011-04-010
- Conditions
- Brain Surgery With Motor Evoked Potential Monitoring, Spine Surgery With Motor Evoked Potential Monitoring
- Keywords
- infusion dose, vecuronium, motor evoked potential, neuromuscular blocking agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Jul 2011 (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.
The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).
Detailed description
The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland). Previously, one to two counts of response to TOF stimulation has been considered to be primary goal of partial neuromuscular blocking needed for intraoperative motor evoked potential monitoring. However, the visualization of twitch height of response to TOF stimulation has been possible with the help of NMT module. For adequate motor evoked potential monitoring, twitch height of T1 or T2 is also as important as simple count of TOF stimulation. The investigators tried to establish a vecuronium infusion strategy as guided by not only count of TOF stimulation but also twitch height of T1 or T2.
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 adjustmentadjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by No. of response to TOF stimulation |
| T1/T0 guided group | Experimental | Other: T1/ T0 guided adjustmentadjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T1 twitch height as compared with control (T0) |
| T2/ T0 guided group | Experimental | Other: T2/ T0 guided adjustmentadjustment of neuromuscular blocking agent infusion dose every 15 minute as guided by T2 twitch height as compared with baseline (T0) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients undergoing neurosurgery with intraoperative motor evoked potential monitoring
Key exclusion criteria (3 listed)
- Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock)
- Patients with hepatic or renal disease with altered metabolism of vecuronium
- Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)
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 adjustmentadjustment of vecuronium infusion dose every 15 minutes as guided by No. of response to TOF stimulation displayed by NMT module. | Other | TOF count guided group |
| T1/ T0 guided adjustmentadjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module. | Other | T1/T0 guided group |
| T2/ T0 guided adjustmentadjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module. | Other | T2/ T0 guided group |
Primary outcome
Amplitude of MEP monitoring
Time frame: every 30 min during MEP monitoring
the value of MEP amplitude every 30 min during MEP monitoring
4 secondary outcomes
latency of MEP monitoring
Time frame: every 30 min during MEP monitoring
Incidence of patient's spontaneous movement
Time frame: from start to end of the MEP monitoring, an expected average of 4 hours
Overall assessment of MEP monitoring quality
Time frame: from start to end of the MEP monitoring, an expected average of 4 hours
Incidence of patient's spontaneous respiration
Time frame: from start to end of the MEP monitoring, an expected average of 4 hours
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 15 May 2012.
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, M.D.,Ph.D. principal investigator
Samsung Medical Center
Won Ho Kim, M.D. 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 adjustment, T1/ T0 guided adjustment and T2/ T0 guided adjustment in people with Brain Surgery With Motor Evoked Potential Monitoring and Spine Surgery With Motor Evoked Potential Monitoring, 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 3 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 15 May 2012. 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?
Amplitude of MEP monitoring (time frame: every 30 min during MEP monitoring). 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 15 May 2012.