Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02285829 · ClinicalTrials.gov registry record
Determination of TOF Test Threshold for Obtaining Reliable Pedicle Screw Stimulation Test During Lumbar Spine Surgery
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 46
- Enrollment target
NCT02285829 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 46 participants.
The verdict
NCT02285829 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 46 participants
- Enrollment target
Study Summary
During lumbar spine fusion surgery intraoperative neurophysiological monitoring is in routine use for prevention of possible nerve injuries during placement of screw into pedicle. Pedicle screw stimulation test is performed to assess if screw placement is encroaching on the nerve roots. Relative distance between the pedicle screw and the neighbouring root can be estimated by the intensity of the current required to activate the root and appropriate muscle. A properly placed screw can be distinguished from those perforating the pedicle wall by its higher minimum level of electrical current needed to elicit a muscle response. The minimum level is deemed as threshold. This test is based on compound muscle action potential (CMAP) and use of neuromuscular blocking agents (NMBA) should be avoided because of possible cause of false negative results of screw stimulation test. Neuromuscular blocking agents, which are in routine use during anesthesia, will have effect on muscle action potential. When NMBA are used current stimulus will depolarize the same number of axons and the associated muscle response will be present but of lower amplitude because some percentage of motor fibers will be blocked by activity of NMBA. At this point, stronger stimulus is needed to recruit additional axons/muscle fibers , and hence, the measured threshold is elevated. Train of four (TOF) test is method used to determine level of neuromuscular blockade, by stimulation of peripheral nerve and following induced muscle contractions. Interpretation of muscle contractions may be by subjective (visual) or objective (quantitative) method. Quantitative TOF test may be used prior screw stimulation test by calculating T4/T1 ratio and obtaining quantitative value which shows level of neuromuscular blockade. Residual neuromuscular blockade may be present before screw stimulation test, and effect on accuracy of this test in this situation was not clearly investigated in recent studies. The purpose of this
Interventions
- DRUG Rocuronium Bromide, Cisatracurium Besylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2015-02-11 |
| Est. Completion | 2018-01-08 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02285829
The ClinicalTrials.gov registry entry for NCT02285829 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 46 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 Rocuronium Bromide, Cisatracurium Besylate is the first listed.
NCT02285829 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02285829 about?
NCT02285829 is a clinical study titled "Determination of TOF Test Threshold for Obtaining Reliable Pedicle Screw Stimulation Test During Lumbar Spine Surgery". During lumbar spine fusion surgery intraoperative neurophysiological monitoring is in routine use for prevention of possible nerve injuries during placement of screw into pedicle. Pedicle screw stimulation test is performed to assess if screw placement is encroaching on the nerve roots. Relative dis...
What is the current status of trial NCT02285829?
This trial is currently completed. The enrollment target is 46 participants. The study started on 2015-02-11. Estimated completion is 2018-01-08.
What interventions are being tested in trial NCT02285829?
The interventions under investigation include: Rocuronium Bromide, Cisatracurium Besylate (DRUG).
Who is sponsoring clinical trial NCT02285829?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.