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| ID | Type | Description | Link |
|---|---|---|---|
| 6296/EST/25 | Other Identifier | Territorial Ethics Committee - Central-East Veneto Area |
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| Name | Class |
|---|---|
| University Hospital, Padua, Italy | UNKNOWN |
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The goal of this prospective observational study is to compare two different methods of monitoring muscle relaxation during anesthesia - acceleromyography (AMG) and electromyography (EMG) - in people with obesity who are having bariatric surgery with general anesthesia and the muscle relaxant rocuronium.
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:
Researchers will also record how easy each device is to use and whether participants have any breathing problems after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular monitoring with electromyography (EMG) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean paired difference in TOF ratio (AMG vs EMG) | Mean difference between acceleromyography (AMG) and electromyography (EMG) measurements of the Train-of-Four (TOF) ratio (unitless) obtained from paired intraoperative recordings. | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to optimal conditions for tracheal intubation | Time from rocuronium administration to achievement of optimal intubation conditions, defined as TOF count = 0 or deep block confirmed by post-tetanic count (PTC). Measured with both AMG and EMG. | From rocuronium administration to tracheal intubation (approximately 1-3 minutes). |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 18-65 years with pathological obesity (Class II with comorbidities or Class III) scheduled for bariatric surgery under general anesthesia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Carron, MD, PhD | Contact | +390498213090 | michele.carron@unipd.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedale - Università di Padova (Padua University Hospital) | Padova | PD | 35127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31903602 | Background | 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. | |
| 38728090 | Background | 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. |
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Individual participant data will not be shared. Aggregate, de-identified study results will be disseminated through peer-reviewed publications and conference presentations
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2025 | Dec 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Neuromuscular monitoring with acceleromyography (AMG) | Procedure | 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. |
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| Maintenance of deep neuromuscular block |
Duration and stability of deep block (PTC < 5) maintained during anesthesia, as measured by AMG and EMG. |
| From induction of anesthesia to start of reversal with sugammadex (approximately 60-120 minutes) |
| Time to recovery of TOF ratio ≥ 0.9 after sugammadex | Time from administration of sugammadex to achievement of TOF ratio ≥ 0.9 with each monitoring method (AMG and EMG). | From administration of sugammadex to achievement of TOF ratio ≥ 0.9 (typically 1-5 minutes). |
| Usability and quality assessment of AMG and EMG monitoring | Overall usability rating using a five-point Likert scale (1 = extremely poor, 5 = optimal) for AMG and EMG monitoring devices. | At the end of anesthesia (single assessment). |
| Incidence of postoperative respiratory complications | Number of participants experiencing respiratory complications (e.g., hypoxemia, airway obstruction, reintubation, or need for assisted ventilation) in the post-anesthesia care unit (PACU). | Through PACU discharge (approximately 1-2 hours after surgery). |
| Perioperative changes in heart rate | Heart rate (beats per minute, bpm) measured at predefined intraoperative and postoperative time points. | From induction of anesthesia through PACU discharge. |
| Perioperative changes in mean arterial pressure | Mean arterial pressure (mmHg) measured at predefined intraoperative and postoperative time points | From induction of anesthesia through PACU discharge |
| Perioperative changes in oxygen saturation (SpO₂) | Oxygen saturation (SpO2), %) measured at predefined intraoperative and postoperative time points. | From induction of anesthesia through PACU discharge |
| Perioperative changes in perfusion index | Perfusion index (Unitless) measured at predefined intraoperative and postoperative time points. | From induction of anesthesia through PACU discharge. |
| 28044330 | 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. |
| 36377554 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |