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NCT01932983 · ClinicalTrials.gov registry record
Clinical Application of "Train of Four" Testing in the Intraoperative Monitoring Setting
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 150
- Enrollment target
NCT01932983 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 150 participants.
The verdict
NCT01932983 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study 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. '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.
Interventions
- DEVICE Train of four test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01932983
The ClinicalTrials.gov registry entry for NCT01932983 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Train of four test is the first listed.
NCT01932983 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01932983 about?
NCT01932983 is a clinical study titled "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...
What is the current status of trial NCT01932983?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2012-04. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01932983?
The interventions under investigation include: Train of four test (DEVICE).
Who is sponsoring clinical trial NCT01932983?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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