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Determination of TOF Test Threshold for Obtaining Reliable Pedicle Screw Stimulation Test During Lumbar Spine Surgery

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuromuscular Blockade

Intervention: Rocuronium Bromide, Cisatracurium Besylate (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Aleksandar Beric, MD, Principal Investigator, Affiliation: Neurologist

Overall contact:
Brane Gavrancic, MD, Phone: 2015648602, Email: brane.gavrancic@nyumc.org


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 study would be to determine changes of screw stimulation thresholds under different range of neuromuscular blockade. Therefore, acceptable neuromuscular blockade threshold (determined by TOF test) acceptable for obtaining reliable screw stimulation test should be determined. Screw stimulation test may be performed when neuromuscular blockade is absent and compared to repeated screw stimulation test when neuromuscular blockade is present. Different levels of neuromuscular blockade may provide different results on screw stimulation test, so if difference is statistically significant, induced neuromuscular blockade level may be set as threshold value, acceptable for obtaining reliable testing results.

Clinical Details

Official title: Determination of TOF Test Threshold for Obtaining Reliable Pedicle Screw Stimulation Test During Lumbar Spine Surgery

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Train of four (TOF) test


Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.


Inclusion Criteria:

- Subjects undergoing lumbar spine fusion surgery with neurophysiologic intraoperative

monitoring when pedicle screw stimulation test is performed.

- Subjects of both gender

- Age 18-85

- With diagnosis of lumbar spinal stenosis.

- All subjects capable of giving informed consent in order to be included for the

study. Exclusion Criteria:

- Subjects with medical history of presence of neuromuscular diseases

- Any renal and liver diseases.

Locations and Contacts

Brane Gavrancic, MD, Phone: 2015648602, Email: brane.gavrancic@nyumc.org

NYU Langone Medical Center, Hospital for Joint Diseases, New York, New York 10003, United States; Recruiting
Brane Gavrancic, Email: Brane.gavrancic@nyumc.org
Aleksandar Beric, MD, Principal Investigator
Brane Gavrancic, MD, Sub-Investigator
Athena Lolis, MD, Sub-Investigator
George Spessot, MD, Sub-Investigator
Additional Information

Starting date: January 2015
Last updated: January 30, 2015

Page last updated: August 23, 2015

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