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ObesityOBAEGNCT07283354

Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

An observational study of Obesity, run by University of Padova at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Neuromuscular monitoring with electromyography (EMG) and Neuromuscular monitoring with acceleromyography (AMG)
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteItaly
Study dates
1 Feb 2026to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults aged 18-65 years with pathological obesity (Class II with comorbidities or Class III) scheduled for bariatric surgery under general anesthesia.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michele Carron, MD, PhD contact

+390498213090

michele.carron@unipd.it

Italy1 site

  • Azienda Ospedale - Università di Padova (Padua University Hospital)

    Padova, PD, 35127

    Michele Carron, +390498213090, michele.carron@unipd.it

Other trials in Italy

About this study

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

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.

Read more

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.

Conditions
Obesity
Being tested
Neuromuscular monitoring with electromyography (EMG), Neuromuscular monitoring with acceleromyography (AMG)
Keywords
Bariatric Surgery, General Anesthesia, Neuromuscular Blockade, Neuromuscular Monitoring, Acceleromyography, Electromyography
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular monitoring with electromyography (EMG)Procedure or surgery

    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 or surgery

    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 groups in NCT07283354
Study groupRoleWhat they receive
Patients with obesity undergoing bariatric surgeryAdults 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.
Receives: Procedure: Neuromuscular monitoring with electromyography (EMG); Procedure: Neuromuscular monitoring with acceleromyography (AMG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Intraoperative period

Secondary outcomes (9)

  1. 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.

    Measured: From rocuronium administration to tracheal intubation (approximately 1-3 minutes).

  2. Maintenance of deep neuromuscular block

    Duration and stability of deep block (PTC < 5) maintained during anesthesia, as measured by AMG and EMG.

    Measured: From induction of anesthesia to start of reversal with sugammadex (approximately 60-120 minutes)

  3. 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).

    Measured: From administration of sugammadex to achievement of TOF ratio ≥ 0.9 (typically 1-5 minutes).

  4. 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.

    Measured: At the end of anesthesia (single assessment).

  5. 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).

    Measured: Through PACU discharge (approximately 1-2 hours after surgery).

  6. Perioperative changes in heart rate

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

    Measured: From induction of anesthesia through PACU discharge.

  7. Perioperative changes in mean arterial pressure

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

    Measured: From induction of anesthesia through PACU discharge

  8. Perioperative changes in oxygen saturation (SpO₂)

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

    Measured: From induction of anesthesia through PACU discharge

  9. Perioperative changes in perfusion index

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

    Measured: From induction of anesthesia through PACU discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07283354
Sponsor's protocol ID
AOP3692_CET
Other IDs
6296/EST/25
Acronym
OBAEG
Status last verified
Aug 2025
First submitted
25 Nov 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Aggregate, de-identified study results will be disseminated through peer-reviewed publications and conference presentations

Publications

  • 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.

    PubMed 31903602

  • 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.

    PubMed 38728090

  • 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.

    PubMed 28044330

  • 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.

    PubMed 36377554

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of Padova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michele Carron, MD, PhD (+390498213090, michele.carron@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean paired difference in TOF ratio (AMG vs EMG) (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07283354, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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