Comparison of Two Monitors That Measure Neuromuscular Function During Surgeries

NCT03987607 | Completed FDA Device

• 1 other identifier: AITT2017/3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuromuscular Blockade

Keywords

neuromuscular monitoring; acceleromyography; electromyography

Outcome Measures

Primary Outcomes (1)

• Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.8-1.0

  Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.8-1.0

  Prior to extubation

Secondary Outcomes (5)

• o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.6-0.79

  During surgery

• o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.4-0.59

  During surgery

• o Agreement between acceleromyography and electromyography derived TOF ratios in the recovery range of 0.2-0.39

  During surgery

• o Agreement between acceleromyography and electromyography derived TOF counts

  During surgery

• o Agreement between acceleromyography and electromyography derived PTC counts

  During surgery

Study Arms (1)

Patients scheduled for elective surgery

Patients scheduled for elective surgery requiring neuromuscular blockade

Device: neuromuscular blockade monitoring

Interventions

neuromuscular blockade monitoring DEVICE

Neuromuscular blockade monitoring via two different types of monitoring devices

Patients scheduled for elective surgery

Eligibility Criteria

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

Study Population

Patients of the University of Debrecen Clinical Center who are scheduled for elective surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tamas Vegh, MD: lead
• Senzime AB: collaborator

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

Location

Related Publications (3)

• Liang SS, Stewart PA, Phillips S. An ipsilateral comparison of acceleromyography and electromyography during recovery from nondepolarizing neuromuscular block under general anesthesia in humans. Anesth Analg. 2013 Aug;117(2):373-9. doi: 10.1213/ANE.0b013e3182937fc4. Epub 2013 Jul 2.

  PMID: 23821356 BACKGROUND

• Kopman AF, Chin W, Cyriac J. Acceleromyography vs. electromyography: an ipsilateral comparison of the indirectly evoked neuromuscular response to train-of-four stimulation. Acta Anaesthesiol Scand. 2005 Mar;49(3):316-22. doi: 10.1111/j.1399-6576.2005.00643.x.

  PMID: 15752395 BACKGROUND

• Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.

  PMID: 28044330 BACKGROUND

MeSH Terms

Interventions

Neuromuscular Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: June 17, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)