Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

Official title

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

Overview

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.

Interventions

• Procedure 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.
• 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.

Primary outcome measures

• Mean paired difference in TOF ratio (AMG vs EMG) [Time frame: Intraoperative period]

Secondary outcome measures (9)

• Time to optimal conditions for tracheal intubation [Time frame: From rocuronium administration to tracheal intubation (approximately 1-3 minutes).]
• Maintenance of deep neuromuscular block [Time frame: From induction of anesthesia to start of reversal with sugammadex (approximately 60-120 minutes)]
• 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).]
• Usability and quality assessment of AMG and EMG monitoring [Time frame: At the end of anesthesia (single assessment).]
• Incidence of postoperative respiratory complications [Time frame: Through PACU discharge (approximately 1-2 hours after surgery).]
• Perioperative changes in heart rate [Time frame: From induction of anesthesia through PACU discharge.]
• Perioperative changes in mean arterial pressure [Time frame: From induction of anesthesia through PACU discharge]
• Perioperative changes in oxygen saturation (SpO₂) [Time frame: From induction of anesthesia through PACU discharge]
• Perioperative changes in perfusion index [Time frame: From induction of anesthesia through PACU discharge.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

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

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. PMID 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. PMID 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. PMID 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. PMID 36377554

Identifiers

NCT: NCT07283354 · AOP3692_CET · 6296/EST/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗