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Starting soon Observational

Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

NCT07283354 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-02-01
Last updated
2025-12-15

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Neuromuscular monitoring with electromyography (EMG)Neuromuscular monitoring with acceleromyography (AMG)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Azienda Ospedale - Università di Padova (Padua University Hospital) Padova PD
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07283354 on ClinicalTrials.gov ↗ ← All trials in Italy