Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia
NCT ID: NCT07283354
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2026-02-01
2026-09-30
Brief Summary
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The main question is: Which method is more accurate and precise in measuring the Train-of-Four (TOF) ratio during surgery? As part of this comparison, researchers will also note how quickly each method detects recovery of muscle function after the reversal drug sugammadex.
Participants will:
* Receive standard anesthesia care for bariatric surgery, including rocuronium to relax the muscles.
* Have two small monitoring devices applied, one to each hand: AMG on one hand, EMG on the other.
* Be monitored for muscle function during surgery and after receiving sugammadex to reverse the muscle relaxation.
Researchers will also record how easy each device is to use and whether participants have any breathing problems after surgery.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with obesity undergoing bariatric surgery
Adults with obesity scheduled for bariatric surgery under general anesthesia. Each participant will be monitored for neuromuscular function using both acceleromyography (AMG) and electromyography (EMG) during surgery and after administration of sugammadex.
Neuromuscular monitoring with electromyography (EMG)
Neuromuscular function will be assessed using an electromyography device applied to the hand. The device measures the electrical activity of muscles in response to ulnar nerve stimulation to calculate the Train-of-Four (TOF) ratio.
Neuromuscular monitoring with acceleromyography (AMG)
Neuromuscular function will be assessed using an acceleromyography device applied to the hand. The device measures the acceleration of thumb movement in response to ulnar nerve stimulation to calculate the Train-of-Four (TOF) ratio.
Interventions
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Neuromuscular monitoring with electromyography (EMG)
Neuromuscular function will be assessed using an electromyography device applied to the hand. The device measures the electrical activity of muscles in response to ulnar nerve stimulation to calculate the Train-of-Four (TOF) ratio.
Neuromuscular monitoring with acceleromyography (AMG)
Neuromuscular function will be assessed using an acceleromyography device applied to the hand. The device measures the acceleration of thumb movement in response to ulnar nerve stimulation to calculate the Train-of-Four (TOF) ratio.
Eligibility Criteria
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Inclusion Criteria
* Pathological obesity (Class II with comorbidities or Class III)
* Scheduled for bariatric surgery under general anesthesia
* Written informed consent obtained
Exclusion Criteria
* Severe acute or recent cardiac disease (e.g., acute or recent myocardial infarction, inducible ischemia, heart failure)
* End-stage hepatic or renal disease
* Intolerance, allergy, or contraindication to study-related drugs
* Absence of informed consent
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Padua, Italy
UNKNOWN
University of Padova
OTHER
Responsible Party
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Locations
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Azienda Ospedale - Università di Padova (Padua University Hospital)
Padua, PD, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Carron M, Safaee Fakhr B, Ieppariello G, Foletto M. Perioperative care of the obese patient. Br J Surg. 2020 Jan;107(2):e39-e55. doi: 10.1002/bjs.11447.
Wedemeyer Z, Michaelsen KE, Jelacic S, Silliman W, Lopez A, Togashi K, Bowdle A. Accuracy and Precision of Three Acceleromyographs, Three Electromyographs, and a Mechanomyograph Measuring the Train-of-four Ratio in the Absence of Neuromuscular Blocking Drugs. Anesthesiology. 2024 Aug 1;141(2):262-271. doi: 10.1097/ALN.0000000000005051.
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.
Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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6296/EST/25
Identifier Type: OTHER
Identifier Source: secondary_id
AOP3692_CET
Identifier Type: -
Identifier Source: org_study_id
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