Gastric Emptying Recovery After GLP-1 RA Cessation

January 21, 2026 updated by: Cheol Lee,MD,PhD,, Wonkwang University Hospital

Time-dependent Recovery of Gastric Emptying After Cessation of Glucagon-like Peptide-1 Receptor Agonists: a Prospective Observational Gastric Ultrasound Study

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) can delay gastric emptying and may increase residual gastric contents before general anesthesia. Current perioperative recommendations for withholding GLP-1 RAs (e.g., a fixed 7-day discontinuation for weekly agents) are largely consensus-based, and it is unclear whether gastric emptying normalizes abruptly after a single threshold interval. This prospective observational cohort study will evaluate how preoperative residual gastric content changes with increasing time since the last GLP-1 RA dose, using point-of-care gastric ultrasound performed immediately before induction of anesthesia. Time since last dose will be analyzed as a continuous exposure and across prespecified intervals (≤3 days, 4-7 days, ≥8 days). The primary outcome is ultrasound-estimated gastric volume normalized to body weight (mL/kg), derived from antral cross-sectional area. Secondary outcomes include the presence of a "high-risk stomach" based on gastric volume criteria and qualitative ultrasound findings. The study will also assess whether body mass index modifies the relationship between cessation interval and gastric volume, thereby supporting individualized perioperative risk assessment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study design and setting: This is a prospective observational cohort study conducted at a tertiary academic hospital to evaluate gastric emptying recovery after cessation of GLP-1 receptor agonists. Adult patients (≥18 years) receiving GLP-1 RAs and scheduled for elective surgery under general anesthesia will be enrolled consecutively to minimize selection bias. Prespecified exclusions include prior gastric or esophageal surgery, known gastroparesis, severe gastroesophageal reflux disease, emergency surgery, pregnancy, and inability to provide informed consent.

Exposure (no intervention assignment): The study does not assign or modify GLP-1 RA therapy. Time since the last GLP-1 RA dose will be recorded in days using patient report and medical records and analyzed both as a continuous variable and as prespecified categories (≤3 days, 4-7 days, ≥8 days). Information on GLP-1 RA formulation (weekly vs daily) and dose equivalence may be collected for sensitivity analyses. Potential confounders such as fasting duration and type of surgery will be recorded.

Gastric ultrasound procedures: Point-of-care gastric ultrasound will be performed immediately before induction of anesthesia using a standardized protocol by trained consultant anesthesiologists. The gastric antrum will be assessed in the supine and right lateral decubitus positions. Qualitative assessment of gastric content will be documented, and quantitative measurements of antral cross-sectional area will be used to estimate gastric volume.

Outcomes: The primary outcome is estimated gastric volume normalized to body weight (mL/kg). Secondary outcomes include the presence of a high-risk stomach, as defined by prespecified gastric volume criteria and qualitative ultrasound findings. Additional exploratory analyses will evaluate whether body mass index modifies the association between cessation interval and gastric volume and whether patient-reported gastrointestinal symptoms correlate with ultrasound findings.

Analysis overview: Associations between time since the last GLP-1 RA dose and gastric ultrasound outcomes will be assessed using prespecified regression models adjusted for relevant covariates (e.g., age, sex, BMI, diabetes status, fasting duration, and symptom measures). The interaction between BMI and cessation interval will be evaluated to characterize potential effect modification.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Jeollabuk-do
      • Iksan, Jeollabuk-do, South Korea, 54538
        • Wonkwang University Hospital
      • Iksan, Jeollabuk-do, South Korea, 54538
        • Wonkwang University School of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients receiving GLP-1 receptor agonists who were scheduled for elective surgery under general anesthesia at a tertiary academic hospital and underwent preoperative point-of-care gastric ultrasound immediately prior to induction of anesthesia.

Description

Inclusion Criteria

  • Adults aged ≥18 years
  • Receiving a glucagon-like peptide-1 receptor agonist (GLP-1 RA)
  • Scheduled for elective surgery under general anesthesia
  • Able to provide written informed consent

Exclusion Criteria

  • Prior gastric or esophageal surgery
  • Known gastroparesis
  • Severe gastroesophageal reflux disease
  • Emergency surgery
  • Pregnancy
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
GLP-1 RA cessation ≤3 days
Participants using GLP-1 receptor agonists whose last dose was taken ≤3 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).
Other: Preoperative gastric ultrasound
Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area. The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified.
Other Names:
  • Point-of-care gastric ultrasound (Gastric POCUS)
GLP-1 RA cessation 4-7 days
Participants using GLP-1 receptor agonists whose last dose was taken 4-7 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).
Other: Preoperative gastric ultrasound
Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area. The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified.
Other Names:
  • Point-of-care gastric ultrasound (Gastric POCUS)
GLP-1 RA cessation ≥8 days
Participants using GLP-1 receptor agonists whose last dose was taken ≥8 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).
Other: Preoperative gastric ultrasound
Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area. The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified.
Other Names:
  • Point-of-care gastric ultrasound (Gastric POCUS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ultrasound-estimated gastric volume (mL/kg)
Time Frame: Immediately preoperatively (just before induction of anesthesia)
Estimated gastric volume normalized to body weight (mL/kg) was calculated from the gastric antral cross-sectional area measured by preoperative point-of-care ultrasound using validated equations.
Immediately preoperatively (just before induction of anesthesia)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perlas grade of gastric content (0-2)
Time Frame: Immediately preoperatively (just before induction of anesthesia)
Qualitative gastric ultrasound grading of gastric content was recorded using the Perlas classification (Grade 0, 1, or 2) based on antral appearance in the supine and right lateral decubitus positions.
Immediately preoperatively (just before induction of anesthesia)
Antral cross-sectional area (CSA, cm²)
Time Frame: Immediately preoperatively (just before induction of anesthesia)
Gastric antral cross-sectional area (cm²) was measured by preoperative ultrasound and used to estimate gastric volume.
Immediately preoperatively (just before induction of anesthesia)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wonkwang University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheol Lee, M.D.,Ph.D, Wonkwang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Wonkwang UH 23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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