Completed

NCT Number: NCT06500143

Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery

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

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Key information

Conditions

Gastric Retention Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIUSSS de l'Est de l'Ile de Montréal

Montreal, Quebec, H1T2M4, Canada

About this study

Background: Glucagon-like peptide-1 receptor agonists (GLP-1RA) are glucose-lowering drugs that act through three mechanisms: stimulation of insulin secretion, inhibition of glucagon secretion and decrease of gastric emptying. The GLP-1RA are now an important part of glycemic control in type 2 diabetes mellitus (T2DM). Recently, GLP-1 RA have received approval for weight loss, expanding their use in overweight or obese non-diabetic patients.The effect of GLP-1RA on decreased gastric emptying has long been established but he clinical implication of this in the periprocedural setting is uncertain. Recent guidelines recommend holding the weekly-dosed for at least a week before elective surgery. Considering the extended half-lives of once-weekly GLP-1RA (approximately 6 days for semaglutide and 5 days for dulaglutide), it is unclear if following those guidelines is sufficient to make sure patients are not at high risk of aspiration

Hypothesis: This study will compare ultrasound-assessed residual gastric content (RGC) between once-weekly GLP-1RA users that stopped their medication for 7 days or more before elective surgery and patients not taking GLP-1RA. The investigators hypothesized that even with appropriate holding of GLP-1RA, those patients may have increased RGC and be at higher risk of aspiration.

Objectives:

Primary objective:

To investigate the relation between GLP-1RA use and increased RGC

Secondary objectives:

To assess the relation between the number of days since the last dose of GLP-1RA and increased RGC
To assess the relation between the dose of GLP-1RA and RGC

Exploratory objectives:

To explore the relation between other known risk factors of gastroparesis and increased RGC
To explore the relation between the time since the last oral intake and increased RGC

Methods : A gastric ultrasound (GUS)will be performed on all patients to assess RGC using a published validated and reproductible method used in recent trials. The acquisition of images will be performed by a blinded anesthesiologist or anesthesiology resident using a dedicated ultrasound machine. The images will be saved and reviewed by another blinded trained anesthesiologist.

Significance/importance: The results of this study could challenge the actual recommendations for GLP-1RA stoppage before surgery and help improve perioperative care for patients taking GLP-1RA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

Gastric ultrasound

Diagnostic 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.

Primary outcomes

Increased residual gastric content

Time frame: Preoperative (day of surgery)
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)]

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Collaborators

Institut de Cardiologie de Montréal

Registry information

Official study title

The RESIDUAL Study : Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery: a Cross-sectional Study

Acronym: RESIDUAL

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 15, 2024
Registry last updated: Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed