- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932983
Clinical Application of "Train of Four" Testing in the Intraoperative Monitoring Setting
Clinical Application of Train of Four Testing in the Intraoperative Monitoring Setting
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10003
- NYU Langone Medical Center, Hospital for Joint Diseases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle contraction - TOF twitch after peripheral nerve stimulation
Time Frame: During spine lumbar surgery after pedicle screw placement
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TOF test is performed after pedicle screw placement during lumbar spine surgery, prior neurophysiological pedicle screw position test.
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During spine lumbar surgery after pedicle screw placement
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aleksandar Beric, MD, NYU Langone Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S12-01499
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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