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NCT Number: NCT07283354

Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedale - Università di Padova (Padua University Hospital)

Padova, PD, 35127, Italy

Location contact

Michele Carron

CONTACT

[email protected]

+390498213090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean paired difference in TOF ratio (AMG vs EMG)

    Time frame: 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 outcomes

  1. Time to optimal conditions for tracheal intubation

    Time frame: 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.

  2. Maintenance of deep neuromuscular block

    Time frame: 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.

  3. Time to recovery of TOF ratio ≥ 0.9 after sugammadex

    Time frame: 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).

  4. Usability and quality assessment of AMG and EMG monitoring

    Time frame: 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.

  5. Incidence of postoperative respiratory complications

    Time frame: 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).

  6. Perioperative changes in heart rate

    Time frame: From induction of anesthesia through PACU discharge.

    Heart rate (beats per minute, bpm) measured at predefined intraoperative and postoperative time points.

  7. Perioperative changes in mean arterial pressure

    Time frame: From induction of anesthesia through PACU discharge

    Mean arterial pressure (mmHg) measured at predefined intraoperative and postoperative time points

  8. Perioperative changes in oxygen saturation (SpO₂)

    Time frame: From induction of anesthesia through PACU discharge

    Oxygen saturation (SpO2), %) measured at predefined intraoperative and postoperative time points.

  9. Perioperative changes in perfusion index

    Time frame: From induction of anesthesia through PACU discharge.

    Perfusion index (Unitless) measured at predefined intraoperative and postoperative time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Carron, MD, PhD

CONTACT

[email protected]

+390498213090

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • University Hospital, Padua, Italy

Registry information

Official study title

Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia With Rocuronium: A Prospective Observational Study

Acronym: OBAEG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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