Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery
RESIDUAL
The RESIDUAL Study : Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery: a Cross-sectional Study
1 other identifier
observational
94
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedStudy Start
First participant enrolled
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedJanuary 16, 2026
December 1, 2025
5 months
July 8, 2024
January 15, 2026
Conditions
Keywords
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
Control group
Participants presenting for elective surgery and not taking semaglutide or dulaglutide
Interventions
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis Morisson, MD, MSc
CIUSS de l'Est de l'Île de Montréal
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