Clinical Application of "Train of Four" Testing in the Intraoperative Monitoring Setting

NCT01932983 | Completed DMC

• 1 other identifier: S12-01499
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Blockade; Muscle Relaxation

Keywords

Neuromuscular blockade; TOF test; Quantitative TOF method; Visual interpretation of TOF

Outcome Measures

Primary Outcomes (1)

• 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.

  During spine lumbar surgery after pedicle screw placement

Study Arms (1)

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.

Device: Train of four test

Interventions

Train of four test DEVICE

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.

TOF test

Eligibility Criteria

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

Study Population

Subjects undergoing instrumented orthopedic surgical procedure which requires the use of neurophysiologic intraoperative monitoring modalities.

You may qualify if:

• Subject undergoing spine fusion surgery when intraoperative neurophysiologic monitoring is included.

You may not qualify if:

• 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.

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

Related Publications (1)

• 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.

  PMID: 25462145 RESULT

Related Links

• Clinical trial of application of train of four testing in the intraoperative monitoring setting

Study Officials

• Aleksandar Beric, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 30, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

US (1)