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Semaglutide and Preoperative Residual Gastric Volumes

U

University of Calgary

Status

Enrolling

Conditions

Pulmonary Aspiration

Treatments

Device: gastric antral sonography

Study type

Observational

Funder types

Other

Identifiers

NCT06263595
REB23-1754

Details and patient eligibility

About

Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.

To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.

Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all elective surgical patients (> 18 years of age)
  • followed institutional fasting protocol for surgery
  • patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
  • patients not taking GLP-1 receptor agonist (N =45)

Exclusion criteria

  • confounding delayed gastric emptying due to pregnancy
  • previous esophageal or gastric operation
  • etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
  • on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)

Trial design

90 participants in 2 patient groups

GLP-1 Agonist Group
Description:
Intervention: elective surgical patients taking GLP-1 receptor agonists
Treatment:
Device: gastric antral sonography
Non GLP-1 Agonist Group
Description:
Intervention: elective surgical patients not taking GLP-1 receptor agonists
Treatment:
Device: gastric antral sonography

Trial contacts and locations

1

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Central trial contact

Joanna J Moser, MD, PhD

Data sourced from clinicaltrials.gov

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