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Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia

ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Padova

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Neuromuscular monitoring with electromyography (EMG)

    Procedure/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/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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with obesity undergoing bariatric surgery2 interventions

Trial outcomes

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.

Time frame
Intraoperative period

Secondary outcomes

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.

Time frame
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.

Time frame
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).

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Padova

Lead sponsor

University Hospital, Padua, Italy

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: