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

Completed

Conditions studied: Neuromuscular Blockade, Muscle Relaxation

In brief

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.

Key facts

Study ID

NCT01932983

Run by

NYU Langone Health

People needed

150

Starts

2012-04-01

Expected to finish

2013-04-01

Last updated by the study team

2015-10-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• NYU Langone Medical Center, Hospital for Joint Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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