Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

NCT07283354 | Not Yet Recruiting

• 2 other identifiers: AOP3692_CET6296/EST/25
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Bariatric Surgery; General Anesthesia; Neuromuscular Blockade; Neuromuscular Monitoring; Acceleromyography; Electromyography

Outcome Measures

Primary Outcomes (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.

  Intraoperative period

Secondary Outcomes (9)

• Time to optimal conditions for tracheal intubation

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

• Maintenance of deep neuromuscular block

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

• 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).

• Usability and quality assessment of AMG and EMG monitoring

  At the end of anesthesia (single assessment).

• Incidence of postoperative respiratory complications

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

Study Arms (1)

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.

Procedure: Neuromuscular monitoring with electromyography (EMG); Procedure: Neuromuscular monitoring with acceleromyography (AMG)

Interventions

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.

Patients with obesity undergoing bariatric surgery

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.

Patients with obesity undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead
• University Hospital, Padua, Italy: collaborator

Study Sites (1)

Azienda Ospedale - Università di Padova (Padua University Hospital)

Padua, PD, 35127, Italy

Location

Related Publications (4)

• 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.

  PMID: 31903602 BACKGROUND

• 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.

  PMID: 38728090 BACKGROUND

• 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.

  PMID: 28044330 BACKGROUND

• 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.

  PMID: 36377554 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Michele Carron, MD, PhD

CONTACT

+390498213090; michele.carron@unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 15, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)