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Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia (OBAEG)

U

University of Padova

Status

Not yet enrolling

Conditions

Obesity

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT07283354
AOP3692_CET
6296/EST/25 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Patients with obesity undergoing bariatric surgery
Description:
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.
Treatment:
Procedure: Neuromuscular monitoring with acceleromyography (AMG)
Procedure: Neuromuscular monitoring with electromyography (EMG)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Michele Carron, MD, PhD

Data sourced from clinicaltrials.gov

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