Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

NCT ID: NCT07283354

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-09-30

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Neuromuscular monitoring with electromyography (EMG)

Intervention Type 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)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Padua, Italy

UNKNOWN

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedale - Università di Padova (Padua University Hospital)

Padua, PD, Italy

Site Status

Countries

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Italy

Central Contacts

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Michele Carron, MD, PhD

Role: CONTACT

+390498213090

Facility Contacts

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Michele Carron

Role: primary

+390498213090

References

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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.

Reference Type BACKGROUND
PMID: 31903602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38728090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28044330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36377554 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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6296/EST/25

Identifier Type: OTHER

Identifier Source: secondary_id

AOP3692_CET

Identifier Type: -

Identifier Source: org_study_id

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