Neuromuscular BlockadeNCT01932983
Clinical Application of "Train of Four" Testing in the Intraoperative Monitoring Setting
An observational study of Neuromuscular Blockade and Muscle Relaxation, run by NYU Langone Health at 1 site in United States.
Trial summary
The study examines the clinical application of TOF (train of four test) used by anesthesiologists and neurophysiologists during instrumented spine procedures, as well as certain associated parameters. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuromuscular Blockade, Muscle Relaxation
- What is being tested?
- Train of four test
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing instrumented orthopedic surgical procedure which requires the use of neurophysiologic intraoperative monitoring modalities.
Who may be able to join
- Subject undergoing spine fusion surgery when intraoperative neurophysiologic monitoring is included.
Who cannot join
- Subjects with history of previous nerve injury or peripheral neuropathies when intraoperative neurophysiologic monitoring was precluded. Possible technical issues during surgery prior TOF test such as incorrect electrode placement, lead wire attachment, TOF device error or impossibility to correct it in acceptable time when TOF test can not be performed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center, Hospital for Joint Diseases
New York, New York, 10003
About this study
Official title: Clinical Application of Train of Four Testing in the Intraoperative Monitoring Setting
The study examines the clinical application of TOF (train of four test) used by anesthesiologists and neurophysiologists during instrumented spine procedures, as well as certain associated parameters. 'Train of four' test is a test routinely used during the surgery, which is performed by stimulation of peripheral nerve with purpose to determine the degree of muscle relaxation by interpretation of muscle response. During spine surgery, it is helpful for the surgeon to have a patient's muscles as relaxed as possible with the least amount of tone, especially when exposing. Anesthesiologists achieve this level of relaxation by giving a neuromuscular blocking agent. If medication given to do this has not fully left their system by the time the surgeon needs to start putting in the screws and rods, then the intraoperative monitoring can not be adequately performed. If the muscles are too relaxed, then free run EMG and screw stimulation, two monitoring methods used, will not be analyzed correctly and the surgery may be adversely affected. This study compares the results of the 'train of four' test performed by neurophysiologists and anesthesiologists. Additionally, it looks at the differences, if any, in comparing stimulation of the foot nerve (tibial n.) or hand nerve (ulnar n.) Performing the TOF (train of four test) in the lower extremity can be relevant for many reasons. Train of four tests can show the presence of four twitches in the arms but the legs may not fully recovered from muscle relaxant given by anesthesia. Also, train of four test which uses subjective method of interpretation by anesthesiologists may present different results compared than objective quantitative method of train of four test interpretation. Ultimately, the goal of this study is to show the importance of 'TOF' testing in ensuring that any identifiable preventable intraoperative surgical complication is appropriately identified.
Read the detailed description
TOF test was performed by two routinely used devices, peripheral nerve stimulator and intraoperative neurophysiologic monitoring device. TOF monitoring of upper extremity included stimulation of ulnar nerve. Negative surface electrode was placed on the wrist in line with the smallest digit 1-2cm below skin crease and the positive 2-3cm proximal to the negative electrode. Active surface recording electrodes were placed on adductor pollicis muscle. TOF monitoring of lower extremity included stimulation of peripheral nerve, posterior tibial nerve. Surface stimulating electrodes were placed, negative over inferolateral aspect of medial malleolus, and positive electrode 2-3cm proximal to the negative electrode. Stimulation current was 20-30 mA for hand and 30-60mA foot TOF by a group of 0.2 millisecond pulses, spaced 500 millisecond apart, to deliver four contractions. Surface recording electrodes were used for measuring muscle response on foot, active electrode which was located on the Flexor hallucis brevis muscle and reference on the big toe. Intraoperative monitoring device was used, and software with TOF monitoring programe was installed. EMG response was calculated by the peak of amplitude (peak to peak amplitude) presented in quantitative value of online measurement. Interpretation was different, visual and subjective. Peripheral nerve stimulator was used for subjective TOF test. Output current was adjustable from 0 to 70 mA. Repeat stimulation of 4 pulses/0.2 milliseconds repeated every 500 milliseconds. Surface negative electrodes were placed over the course of ulnar nerve on the wrist, in line with the smallest digit, 1-2cm proximal from skin crease, and positive electrode 2-3 cm proximal. Response was followed on adductor pollicis muscle. All data were kept in electronic medical records and if data are not complete subjects were not included in the study. Results were compared between TOF methods on two different body sites, upper and lower extremity, by quantitative method and other comparison was made between subjective and quantitative method with TOF test located in both methods on the upper extremity.
- Conditions
- Neuromuscular Blockade, Muscle Relaxation
- Being tested
- Train of four test
- Keywords
- Neuromuscular blockade, TOF test, Quantitative TOF method, Visual interpretation of TOF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train of four testDevice
TOF test includes stimulation of peripheral nerve of upper extremity, ulnar nerve in this study. Two methods of interpretation are included, visual which uses anesthesiologist TOF device, and quantitative uses intraoperative neurophysiologic monitoring device, both devices are in routine clinical practice use. Different interpretation of muscle contractions are followed, by quantitative method and visual method. Visual evaluates number of twitches and determines the degree of neuromuclular block and percent of blocked acetylcholine receptors. Quantitative method record muscle contraction by using EMG, presents each twitch as amplitude, caluculate peak to peak value, and provide numerical value and difference for each twitch.
| Study group | Role | What they receive |
|---|---|---|
| TOF test | TOF - train of four test performed on patiens undergoing lumbar spine surgery where introperative neurophysiologic monitoring is applied. Stimulation of peripheral nerve - ulnar nerve resulting with muscle contractions and evaluation of responses by anesthesiologist and neurophysiologists. Stimulation with group of 0.2 millisecond pulses, spaced 500 millisecond apart, at a 2 Hz rate, current 20-60 mA to deliver four muscle contractions. Eligibility criteria included patients for study where subjective visual interpretation and quantitative interpretation of Adductor pollicis muscle responses is followed. Receives: Device: Train of four test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle contraction - TOF twitch after peripheral nerve stimulation
TOF test is performed after pedicle screw placement during lumbar spine surgery, prior neurophysiological pedicle screw position test.
Measured: During spine lumbar surgery after pedicle screw placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startApr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandar Beric, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932983
- Sponsor's protocol ID
- S12-01499
- Status last verified
- Oct 2015
- First submitted
- 26 Aug 2013
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gavrancic B, Lolis A, Beric A. Train-of-four test in intraoperative neurophysiologic monitoring: differences between hand and foot train-of-four. J Clin Neurophysiol. 2014 Dec;31(6):575-9. doi: 10.1097/WNP.0000000000000111.
PubMed 25462145
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Train of Four Testing in the Intraoperative Monitoring Setting
- ClinicalTrials.gov ID
- NCT01932983
- Acronym / sponsor ID
- S12-01499
- Conditions
- Neuromuscular Blockade, Muscle Relaxation
- Keywords
- Neuromuscular blockade, TOF test, Quantitative TOF method, Visual interpretation of TOF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Aug 2013 (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 study examines the clinical application of TOF (train of four test) used by anesthesiologists and neurophysiologists during instrumented spine procedures, as well as certain associated parameters. 'Train of four' test is a test routinely used during the surgery, which is performed by stimulation of peripheral nerve with purpose to determine the degree of muscle relaxation by interpretation of muscle response. During spine surgery, it is helpful for the surgeon to have a patient's muscles as relaxed as possible with the least amount of tone, especially when exposing. Anesthesiologists achieve this level of relaxation by giving a neuromuscular blocking agent. If medication given to do this has not fully left their system by the time the surgeon needs to start putting in the screws and rods, then the intraoperative monitoring can not be adequately performed. If the muscles are too relaxed, then free run EMG and screw stimulation, two monitoring methods used, will not be analyzed correctly and the surgery may be adversely affected. This study compares the results of the 'train of four' test performed by neurophysiologists and anesthesiologists. Additionally, it looks at the differences, if any, in comparing stimulation of the foot nerve (tibial n.) or hand nerve (ulnar n.) Performing the TOF (train of four test) in the lower extremity can be relevant for many reasons. Train of four tests can show the presence of four twitches in the arms but the legs may not fully recovered from muscle relaxant given by anesthesia. Also, train of four test which uses subjective method of interpretation by anesthesiologists may present different results compared than objective quantitative method of train of four test interpretation. Ultimately, the goal of this study is to show the importance of 'TOF' testing in ensuring that any identifiable preventable intraoperative surgical complication is appropriately identified.
Detailed description
TOF test was performed by two routinely used devices, peripheral nerve stimulator and intraoperative neurophysiologic monitoring device. TOF monitoring of upper extremity included stimulation of ulnar nerve. Negative surface electrode was placed on the wrist in line with the smallest digit 1-2cm below skin crease and the positive 2-3cm proximal to the negative electrode. Active surface recording electrodes were placed on adductor pollicis muscle. TOF monitoring of lower extremity included stimulation of peripheral nerve, posterior tibial nerve. Surface stimulating electrodes were placed, negative over inferolateral aspect of medial malleolus, and positive electrode 2-3cm proximal to the negative electrode. Stimulation current was 20-30 mA for hand and 30-60mA foot TOF by a group of 0.2 millisecond pulses, spaced 500 millisecond apart, to deliver four contractions. Surface recording electrodes were used for measuring muscle response on foot, active electrode which was located on the Flexor hallucis brevis muscle and reference on the big toe. Intraoperative monitoring device was used, and software with TOF monitoring programe was installed. EMG response was calculated by the peak of amplitude (peak to peak amplitude) presented in quantitative value of online measurement. Interpretation was different, visual and subjective. Peripheral nerve stimulator was used for subjective TOF test. Output current was adjustable from 0 to 70 mA. Repeat stimulation of 4 pulses/0.2 milliseconds repeated every 500 milliseconds. Surface negative electrodes were placed over the course of ulnar nerve on the wrist, in line with the smallest digit, 1-2cm proximal from skin crease, and positive electrode 2-3 cm proximal. Response was followed on adductor pollicis muscle. All data were kept in electronic medical records and if data are not complete subjects were not included in the study. Results were compared between TOF methods on two different body sites, upper and lower extremity, by quantitative method and other comparison was made between subjective and quantitative method with TOF test located in both methods on the upper extremity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOF test | – | Device: Train of four testTOF - train of four test performed on patiens undergoing lumbar spine surgery where introperative neurophysiologic monitoring is applied. Stimulation of peripheral nerve - ulnar nerve resulting with muscle contractions and evaluation of responses by anesthesiologist and neurophysiologists. Stimulation with group of 0.2 millisecond pulses, spaced 500 millisecond apart, at a 2 Hz rate, current 20-60 mA to deliver four muscle contractions. Eligibility criteria included patients for study where subjective visual interpretation and quantitative interpretation of Adductor pollicis muscle responses is followed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing instrumented orthopedic surgical procedure which requires the use of neurophysiologic intraoperative monitoring modalities.
Key inclusion criteria (1 listed)
- Subject undergoing spine fusion surgery when intraoperative neurophysiologic monitoring is included.
Key exclusion criteria (1 listed)
- Subjects with history of previous nerve injury or peripheral neuropathies when intraoperative neurophysiologic monitoring was precluded. Possible technical issues during surgery prior TOF test such as incorrect electrode placement, lead wire attachment, TOF device error or impossibility to correct it in acceptable time when TOF test can not be performed.
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 |
|---|---|---|
| Train of four testTOF test includes stimulation of peripheral nerve of upper extremity, ulnar nerve in this study. Two methods of interpretation are included, visual which uses anesthesiologist TOF device, and quantitative uses intraoperative neurophysiologic monitoring device, both devices are in routine clinical practice use. Different interpretation of muscle contractions are followed, by quantitative method and visual method. Visual evaluates number of twitches and determines the degree of neuromuclular block and percent of blocked acetylcholine receptors. Quantitative method record muscle contraction by using EMG, presents each twitch as amplitude, caluculate peak to peak value, and provide numerical value and difference for each twitch. | Device | TOF test |
Primary outcome
Muscle contraction - TOF twitch after peripheral nerve stimulation
Time frame: During spine lumbar surgery after pedicle screw placement
TOF test is performed after pedicle screw placement during lumbar spine surgery, prior neurophysiological pedicle screw position test.
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 27 Oct 2015.
- Results publication: PubMed 25462145Gavrancic B, Lolis A, Beric A. Train-of-four test in intraoperative neurophysiologic monitoring: differences between hand and foot train-of-four. J Clin Neurophysiol. 2014 Dec;31(6):575-9. doi: 10.1097/WNP.0000000000000111.
- Clinical trial of application of train of four testing in the intraoperative monitoring settingLink provided by the sponsor.
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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.
Aleksandar Beric, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Muscle Relaxation, run by NYU Langone Health at 1 site in United States.
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 1 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 27 Oct 2015. 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 United States. 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?
Muscle contraction - TOF twitch after peripheral nerve stimulation (time frame: During spine lumbar surgery after pedicle screw placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932983, which also lists 1 linked publication.
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 27 Oct 2015.