Obesity
Conditions
Keywords
Bariatric Surgery, General Anesthesia, Neuromuscular Blockade, Neuromuscular Monitoring, Acceleromyography, Electromyography
Brief summary
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: * 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.
Interventions
PROCEDURENeuromuscular 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.
PROCEDURENeuromuscular 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.
Sponsors
University Hospital, Padua, Italy
University of Padova
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years * 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 chronic respiratory disease (e.g., asthma, COPD, severe restrictive disease) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean paired difference in TOF ratio (AMG vs EMG) | Intraoperative period | Mean difference between acceleromyography (AMG) and electromyography (EMG) measurements of the Train-of-Four (TOF) ratio (unitless) obtained from paired intraoperative recordings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of deep neuromuscular block | From induction of anesthesia to start of reversal with sugammadex (approximately 60-120 minutes) | Duration and stability of deep block (PTC \< 5) maintained during anesthesia, as measured by AMG and EMG. |
| Time to recovery of TOF ratio ≥ 0.9 after sugammadex | From administration of sugammadex to achievement of TOF ratio ≥ 0.9 (typically 1-5 minutes). | Time from administration of sugammadex to achievement of TOF ratio ≥ 0.9 with each monitoring method (AMG and EMG). |
| Usability and quality assessment of AMG and EMG monitoring | At the end of anesthesia (single assessment). | Overall usability rating using a five-point Likert scale (1 = extremely poor, 5 = optimal) for AMG and EMG monitoring devices. |
| Incidence of postoperative respiratory complications | Through PACU discharge (approximately 1-2 hours after surgery). | Number of participants experiencing respiratory complications (e.g., hypoxemia, airway obstruction, reintubation, or need for assisted ventilation) in the post-anesthesia care unit (PACU). |
| Time to optimal conditions for tracheal intubation | From rocuronium administration to tracheal intubation (approximately 1-3 minutes). | 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. |
| Perioperative changes in mean arterial pressure | From induction of anesthesia through PACU discharge | Mean arterial pressure (mmHg) measured at predefined intraoperative and postoperative time points |
| Perioperative changes in oxygen saturation (SpO₂) | From induction of anesthesia through PACU discharge | Oxygen saturation (SpO2), %) measured at predefined intraoperative and postoperative time points. |
| Perioperative changes in perfusion index | From induction of anesthesia through PACU discharge. | Perfusion index (Unitless) measured at predefined intraoperative and postoperative time points. |
| Perioperative changes in heart rate | From induction of anesthesia through PACU discharge. | Heart rate (beats per minute, bpm) measured at predefined intraoperative and postoperative time points. |
Countries
Italy
Contacts
Primary ContactMichele Carron, MD, PhD
Outcome results
None listed