Semaglutide and Preoperative Residual Gastric Volumes

NCT06263595 | Completed

• 1 other identifier: REB23-1754
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Aspiration

Outcome Measures

Primary Outcomes (1)

• Number of participants presenting with a full stomach

  Full stomach defined as either clear fluid \> 1.5ml/kg or solid content found with point-of-care gastric antral sonography.

  Measured in the preoperative holding area

Secondary Outcomes (3)

• Number of occurrences requiring change in anesthetic management plan

  From time of preoperative ultrasound in holding area to anesthesia induction in operating room

• Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume

  Measured in the preoperative holding area

• Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration

  Measured in the preoperative holding area

Study Arms (2)

GLP-1 Agonist Group

Intervention: elective surgical patients taking GLP-1 receptor agonists

Device: gastric antral sonography

Non GLP-1 Agonist Group

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

Device: gastric antral sonography

Interventions

gastric antral sonography 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.

GLP-1 Agonist Group; Non GLP-1 Agonist Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective surgical patients meeting inclusion/exclusion criteria at the South Health Campus (Calgary, AB, Canada)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: May 31, 2024
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)