NCT06500143

Brief Summary

Glucagon-like peptide-1 agonists (GLP-1RA) are a family of medications used for diabetes and weight loss. One of their effect is to slow down stomach emptying. The goal of this study is to evaluate the effect of GLP-1RA on the effectiveness of fasting before a scheduled surgery. The question it aims to answer is: does this kind of medication increase the risk of having food or too much liquid in the stomach before a scheduled surgery, even if the minimum 6 hour fast is done? For this project, researchers will use gastric ultrasound to compare participants already taking one of these medications as part of their home treatment to participants who are not taking them. Gastric ultrasound is a simple bedside exam using an echography machine that takes less than 5 minutes to do. Participants will:

  • Have a gastric ultrasound performed on them before their surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

July 8, 2024

Last Update Submit

January 15, 2026

Conditions

Keywords

glucagon-like peptide 1gastric ultrasoundsurgerydiabetesweight lossincreased residual gastric contentsemaglutidedulaglutide

Outcome Measures

Primary Outcomes (1)

  • Increased residual gastric content

    The primary endpoint will be the prevalence of increased residual gastric content defined by the presence of any of the following: * Solid or thick fluid content on gastric ultrasound * Content of more than 1.5 mL/kg of clear fluids on gastric ultrasound using the following formula : Gastric volume (mL) = 27 + \[14.6 × right lateral cross-sectional area (in cm2)\] - \[1.28 × age (in years)\]

    Preoperative (day of surgery)

Study Arms (2)

GLP-1RA agonists users

Participants presenting for elective surgery and taking once-weekly semaglutide or dulaglutide as part of their usual treatment with the last dose at least 7 days before surgery

Diagnostic Test: Gastric ultrasound

Control group

Participants presenting for elective surgery and not taking semaglutide or dulaglutide

Diagnostic Test: Gastric ultrasound

Interventions

Gastric ultrasoundDIAGNOSTIC_TEST

Using a curved array low-frequency abdominal probe (2-5 MHz) with abdominal presets and with the patient in right lateral decubitus position, the gastric antrum will be identified in a standardized plane at the level of the aorta. The stomach will be considered empty if the antrum appears flat or round with anterior and posterior walls collapsed. Normal gastric secretions and clear fluids have an anechoic or hypoechoic aspect on ultrasonography. Solid or thick fluids have a hyperechoic aspect and can create "ring-down" artifacts blurring gastric content, its posterior wall, the pancreas and the aorta. Following qualitative examination, quantitative assessment will be performed if there is presence of clear fluids. The cross-sectional area (CSA) of the antrum will be measured with three measurements to calculate a mean value.

Control groupGLP-1RA agonists users

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult population undergoing elective surgery

You may qualify if:

  • American Society of Anesthesiologists (ASA) class 1-4 patients
  • Age ≥ 18 years old
  • Fasted state (2 hours for clear liquids, 6 hours for solids)
  • Elective surgery
  • Last dose of once-weekly semaglutide or dulaglutide 7 days or more before surgery (for GLP-1RA group)

You may not qualify if:

  • Last dose of GLP-1RA less than 7 days before surgery
  • Inability to lay on the right-side for ultrasound
  • Pregnancy
  • History of gastric surgery or large hiatal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS de l'Est de l'Ile de Montréal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Louis Morisson, MD, MSc

    CIUSS de l'Est de l'Île de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

October 9, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

January 16, 2026

Record last verified: 2025-12

Locations