Semaglutide and Preoperative Residual Gastric Volumes

NCT ID: NCT06263595

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Aspiration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GLP-1 Agonist Group

Intervention: elective surgical patients taking GLP-1 receptor agonists

gastric antral sonography

Intervention Type DEVICE

Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.

Non GLP-1 Agonist Group

Intervention: elective surgical patients not taking GLP-1 receptor agonists

gastric antral sonography

Intervention Type DEVICE

Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.

Interventions

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gastric antral sonography

Participant will undergo gastric antrum ultrasound and be scanned in the supine position followed by the right lateral decubitus position. Qualitative and quantitative assessments will be completed.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Health services

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Joanna Moser

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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South Health Campus

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Joanna J Moser, MD, PhD

Role: CONTACT

403-956-3883

Facility Contacts

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Joanna J Moser, MD, PhD

Role: primary

403-956-3883

Other Identifiers

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REB23-1754

Identifier Type: -

Identifier Source: org_study_id

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