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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932983
• Other study ID #: S12-01499
• Status: Completed
• Phase: N/A
• First received: August 26, 2013
• Last updated: October 26, 2015
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

TOF test was performed by two routinely used devices, peripheral nerve stimulator and intraoperative neurophysiologic monitoring device. TOF monitoring of upper extremity included stimulation of ulnar nerve. Negative surface electrode was placed on the wrist in line with the smallest digit 1-2cm below skin crease and the positive 2-3cm proximal to the negative electrode. Active surface recording electrodes were placed on adductor pollicis muscle. TOF monitoring of lower extremity included stimulation of peripheral nerve, posterior tibial nerve. Surface stimulating electrodes were placed, negative over inferolateral aspect of medial malleolus, and positive electrode 2-3cm proximal to the negative electrode. Stimulation current was 20-30 mA for hand and 30-60mA foot TOF by a group of 0.2 millisecond pulses, spaced 500 millisecond apart, to deliver four contractions. Surface recording electrodes were used for measuring muscle response on foot, active electrode which was located on the Flexor hallucis brevis muscle and reference on the big toe. Intraoperative monitoring device was used, and software with TOF monitoring programe was installed. EMG response was calculated by the peak of amplitude (peak to peak amplitude) presented in quantitative value of online measurement. Interpretation was different, visual and subjective. Peripheral nerve stimulator was used for subjective TOF test. Output current was adjustable from 0 to 70 mA. Repeat stimulation of 4 pulses/0.2 milliseconds repeated every 500 milliseconds. Surface negative electrodes were placed over the course of ulnar nerve on the wrist, in line with the smallest digit, 1-2cm proximal from skin crease, and positive electrode 2-3 cm proximal. Response was followed on adductor pollicis muscle. All data were kept in electronic medical records and if data are not complete subjects were not included in the study. Results were compared between TOF methods on two different body sites, upper and lower extremity, by quantitative method and other comparison was made between subjective and quantitative method with TOF test located in both methods on the upper extremity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Muscle Relaxation
• Neuromuscular Blockade

Intervention

Device:
• Train of four test
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.

Locations

Country	Name	City	State
United States	NYU Langone Medical Center, Hospital for Joint Diseases	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

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