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Comparison of Two Monitors That Measure Neuromuscular Function During Surgeries

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ClinicalTrials.gov Identifier: NCT03987607
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Senzime AB
Information provided by (Responsible Party):
Tamas Vegh, MD, University of Debrecen

Brief Summary:
Anesthesiologists are often required to give certain drugs, called muscle relaxants to the patients for surgery. These drugs make the people weak for the procedure to make the work of the surgeon easier and prevent unexpected movements. The effect of these drugs must be terminated by the end of the procedures to ensure that the patients can breathe normally. Over the years several monitors have been developed to monitor the effect of these drugs. The monitors use different principles to measure muscle function. Some monitors are integrated into anesthesia machines while others are battery-operated, portable devices. The aim of the present study is two compare monitors using different technologies. Both monitors stimulate a peripheral nerve at the wrist that makes the thumb twitch. The older device (TOF-Watch SX) measures the acceleration of thumb movement, the new device (TetraGraph) measures the electrical activity of the muscle that moves the thumb. The two devices will be connected so that with one simulation both types of signals can be recorded and analyzed. The monitors will be used during the surgeries as described by the manufacturer. The study will not influence the surgical procedure or the anesthetic of the patients. The aim of the study is to collect data on how the two monitors correlate, since they measure neuromuscular function by different technologies (acceleromyography and electromyography).

Condition or disease Intervention/treatment
Neuromuscular Blockade Device: neuromuscular blockade monitoring

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Electromyography-based TetraGraph and Acceleromyography-based TOF-Watch SX Neuromuscular Monitors Under Clinical Conditions
Estimated Study Start Date : June 17, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
Patients scheduled for elective surgery
Patients scheduled for elective surgery requiring neuromuscular blockade
Device: neuromuscular blockade monitoring
Neuromuscular blockade monitoring via two different types of monitoring devices




Primary Outcome Measures :
  1. Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.8-1.0 [ Time Frame: Prior to extubation ]
    Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.8-1.0


Secondary Outcome Measures :
  1. o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.6-0.79 [ Time Frame: During surgery ]
    o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.6-0.79

  2. o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.4-0.59 [ Time Frame: During surgery ]
    o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.4-0.59

  3. o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.2-0.39 [ Time Frame: During surgery ]
    o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.2-0.39

  4. o Agreement between acceleromyography and electromyography derived TOF counts [ Time Frame: During surgery ]
    o Agreement between acceleromyography and electromyography derived TOF counts

  5. o Agreement between acceleromyography and electromyography derived PTC counts [ Time Frame: During surgery ]
    o Agreement between acceleromyography and electromyography derived PTC counts



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the University of Debrecen Clinical Center who are scheduled for elective surgery
Criteria

Inclusion Criteria:

  • elective surgery requiring neuromuscular blockade
  • written informed consent
  • American Society of Anesthesiology physical status I-III

Exclusion Criteria:

  • neuromuscular disease in patient history,
  • patient taking any medication that affects neuromuscular transmission,
  • open wound or sores at the site of electrode placement,
  • expected difficult airway,
  • pregnancy or breastfeeding state,
  • implanted pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987607


Contacts
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Contact: Réka Nemes, MD +36309668722 reka.nemes.11@gmail.com
Contact: Béla Fülesdi, MD,PhD,DSci +3652255347 fulesdi@med.unideb.hu

Locations
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Hungary
University of Debrecen, Department of Anesthesiology and Intensive Care Recruiting
Debrecen, Hungary, 4032
Contact: Réka Nemes, MD    +36309668722    reka.nemes.11@gmail.com   
Contact: Béla Fülesdi, MD, PhD, Dsci    +3652255347    fulesdi@med.unideb.hu   
Sponsors and Collaborators
Tamas Vegh, MD
Senzime AB

Publications:
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Responsible Party: Tamas Vegh, MD, associate professor, University of Debrecen
ClinicalTrials.gov Identifier: NCT03987607     History of Changes
Other Study ID Numbers: AITT2017/3
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tamas Vegh, MD, University of Debrecen:
neuromuscular monitoring
acceleromyography
electromyography