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

NCT02285829 | Completed

• 1 other identifier: 14-01568
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Train of four (TOF) test

  T4/T1 ratio will be determined and measured prior pedicle screw stimulation test, during lumbar spine surgery. Data will be obtained and followed from participants during one day, while surgery is performed.

  TOF test measure will be performed during the day of surgery prior pedicle screw stimulation test

Study Arms (4)

T4/T1=0.1-0.25

Continuous infusion will commence at the lower dose indicated (0.01mg/kg/min IV for Rocuronium, 0.5 µg/kg/min for Cisatracurium ), and TOF ratios will be monitored every 20 seconds. T4/T1 ratio of quantitative TOF test will be measured, prior pedicle screw stimulation test. When TOF ratio ranges 0.1-0.25, values of pedicle screw stimulation test will be then measured and recorded in milliamps (mA) after TOF test is performed.

Drug: Rocuronium Bromide, Cisatracurium Besylate

T4/T1=0.25-0.50

Continuous infusion will commence at the lower dose indicated (0.01mg/kg/min IV for Rocuronium Bromide, 0.5 µg/kg/min for Cisatracurium Besylate ), and TOF ratios will be monitored every 20 seconds. T4/T1 ratio of quantitative TOF test will be measured, prior pedicle screw stimulation test. When TOF ratio ranges 0.25-0.50, values of pedicle screw stimulation test will be then measured and recorded in milliamps (mA) after TOF test is performed.

Drug: Rocuronium Bromide, Cisatracurium Besylate

T4/T1=0.50-0.75

Continuous infusion will commence at the lower dose indicated (0.01mg/kg/min IV for Rocuronium Bromide, 0.5 µg/kg/min for Cisatracurium Besylate ), and TOF ratios will be monitored every 20 seconds. T4/T1 ratio of quantitative TOF test will be measured, prior pedicle screw stimulation test. When TOF ratio ranges 0.50-0.75, values of pedicle screw stimulation test will be then measured and recorded in milliamps (mA) after TOF test is performed.

Drug: Rocuronium Bromide, Cisatracurium Besylate

T4/T1=0.75-0.90

Continuous infusion will commence at the lower dose indicated (0.01mg/kg/min IV for Rocuronium Bromide, 0.5 µg/kg/min for Cisatracurium Besylate ), and TOF ratios will be monitored every 20 seconds. T4/T1 ratio of quantitative TOF test will be measured, prior pedicle screw stimulation test. When TOF ratio ranges 0.75-0.90, values of pedicle screw stimulation test will be then measured and recorded in milliamps (mA) after TOF test is performed.

Drug: Rocuronium Bromide, Cisatracurium Besylate

Interventions

Rocuronium Bromide, Cisatracurium Besylate DRUG

Both Rocuronium Bromide and Cisatracurium Besylate are administered intravenously following induction of anesthesia initially by bolus, and subsequently re-bolused or administered in continuous infusion as clinically indicated to maintain muscle relaxation. Initial doses of Rocuronium range from 0.45 to 1.2 mg/kg IV, and doses for continuous infusion range from 0.01-0.012 mg/kg/min IV. Initial doses of Cisatracurium range from 0.15 to 0.2 mg/kg, and doses for continuous infusion range from 0.5 to 3 µg/kg/min. Following recovery and baseline screw stimulation at TOF \>0.9, the dosing regimen for this study will rely on restarting a continuous infusion, and adjusting the infusion until the desired TOF ratios are reached. Following screw stimulations and data collection, the infusion will be terminated, and neuromuscular blockade allowed to recover.

Also known as: Zemurone, Nimbex

T4/T1=0.1-0.25; T4/T1=0.25-0.50; T4/T1=0.50-0.75; T4/T1=0.75-0.90

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing elective lumbar spine fusion surgery

You may qualify if:

• 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.

You may not qualify if:

• Subjects with medical history of presence of neuromuscular disease

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center, Hospital for Joint Diseases

New York, New York, 10003, United States

Location

MeSH Terms

Interventions

Rocuronium; cisatracurium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Aleksandar Beric, MD

  Neurologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 7, 2014
• Study Start: February 11, 2015
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

US (1)