Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

N/ANot Yet RecruitingNCT07283354

University of Padova30 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Azienda Ospedale - Università di Padova (Padua University Hospital)

Padova, PD, Italy

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative period

Secondary Outcomes

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.

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

Maintenance of deep neuromuscular block

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

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 from administration of sugammadex to achievement of TOF ratio ≥ 0.9 with each monitoring method (AMG and EMG).

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

Overall usability rating using a five-point Likert scale (1 = extremely poor, 5 = optimal) for AMG and EMG monitoring devices.

Time frame: At the end of anesthesia (single assessment).

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).

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

Perioperative changes in heart rate

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

Time frame: From induction of anesthesia through PACU discharge.

Perioperative changes in mean arterial pressure

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

Time frame: From induction of anesthesia through PACU discharge

Perioperative changes in oxygen saturation (SpO₂)

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

Time frame: From induction of anesthesia through PACU discharge

Perioperative changes in perfusion index

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

Time frame: From induction of anesthesia through PACU discharge.

Central Contacts

Michele Carron, MD, PhD

CONTACT

+390498213090 michele.carron@unipd.it

Data from ClinicalTrials.gov

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