Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07251803

GLP1 Fasting Status and Gastric Retention Using Gastric Ultrasound

This study will enroll patients 18 years and older who are taking a GLP-1/GIP medication and 1) are scheduled for elective surgery and meet ASA fasting guidelines (nothing by mouth for at least 8 hours prior), or 2) scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior. Participants will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The purpose of this study is to determine if people taking GLP-1 receptor agonists and who fast normally are at an equal risk for having retained gastric contents after appropriately fasting for surgery, compared to patients who are on a liquid only diet for 24 hours prior to surgery.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Christopher Wolla, M.D.

PRINCIPAL_INVESTIGATOR

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

About this study

Patients will be classified into one of two groups:

  • Taking a GLP-1/GLP-GIP medication and undergoing an elective colonoscopy and have been on a clear liquid diet for the past 24-hours.

or

  • Taking a GLP-1/GLP-GIP medication and undergoing am elective surgery and have fasted appropriately according to ASA guidelines.

All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. This will be completed to determine the amount of retained gastric contents, if any, after fasting properly prior to the procedure. An anesthesiologist attending who is properly trained on performing gastric ultrasounds and listed as a study team member will be the one performing the scan.

The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position (RLD), and the above procedure will be repeated. The measurement of gastric antral cross-sectional area while in the RLD position will be recorded and used to calculate the gastric volume.

If based on the formula: GV (mL) = 27.0+(14.6*CSA)-(1.28*age) the patient is shown to have a gastric volume greater than 1.5mL/kg, or Antral Grade 2, the anesthesiologist assigned to the case will be alerted and will determine whether or not it is safe to continue with the scheduled surgery as the risk for aspiration may be higher based on the gastric ultrasound results.

Qualitative grading of the appearance of the gastric antrum in RLD will be graded as follows:

  • Grade 0 antrum appears empty in both positions, and suggests no gastric content is present.
  • Grade 1 antrum appears empty in the supine position, but clear fluid is visible in the RLD, consistent with a small volume of gastric fluid.
  • Grade 2 antrum is that in which clear fluid is evident in both patient positions, or any solids in any position which is consistent with a higher volume state.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18+
  • Have taken a GLP-1 or GLP-GIP agonist medication within the past 30 days
  • ASA Physical Classification Status 1-3
  • Fall into one of the following groups:
  • Scheduled elective surgery and meet ASA fasting guidelines (NPO for at least 8 hours prior)
  • Scheduled elective colonoscopy and have been on a clear liquid diet for at least 24 hours prior

Exclusion criteria

  • Previous gastric or esophageal surgery
  • Abnormal gastric anatomy
  • Pregnancy
  • Unable to provide written, informed consent
  • Non-English speaking

Treatment and study plan

Gastric ultrasound

Diagnostic Test

All participants will undergo a gastric ultrasound in the preoperative area prior to their scheduled procedure. The patient will be placed in supine position. A curvilinear ultrasound probe will be placed on the sagittal plane below the xiphoid process. The probe will then slide along the costal margin to the right until the gastric antrum is identified. At this point, the ultrasound image will be obtained, and appropriate measurements will be taken. The patient will be placed in the right lateral decubitus position (RLD), and the above procedure will be repeated. The measurement of gastric antral cross-sectional area while in the RLD position will be recorded and used to calculate the gastric volume.

Primary outcomes

  1. Pre-operative gastric volume per unit of weight (ml/kg) as assessed by gastric ultrasound.

    Time frame: From enrollment until completion of pre-operative gastric ultrasound (typically within 3 hours of scheduled procedure).

    While the patient is in supine position, the gastric volume will be measured via ultrasound and then calculated using a validated formula, GV (mL) = 27.0+(14.6*CSA)-(1.28*age).

Secondary outcomes

  1. Perlas antral grade

    Time frame: From enrollment until completion of gastric ultrasound (within 3 hours of scheduled procedure).

    Qualitative grading of the appearance of the gastric antrum in right lateral decubitus (RLD) will be graded as follows:1

    • Grade 0 antrum appears empty in both positions, and suggests no gastric content is present.
    • Grade 1 antrum appears empty in the supine position, but clear fluid is visible in the RLD, consistent with a small volume of gastric fluid.
    • Grade 2 antrum is that in which clear fluid is evident in both patient positions, or any solids in any position which is consistent with a higher volume state.
  2. Incidence of full stomach on gastric ultrasound assessment

    Time frame: From time of enrollment until the start of surgery, up to 24 hours.

    Incidence of full stomach defined as solid or thick liquids on US or >1.5mL/kg of clear liquid upon gastric ultrasound.

  3. Incidence of regurgitation under anesthesia

    Time frame: From induction of anesthesia until end of surgery (up to 8 hours).

  4. Incidence of change in anesthetic management based on stomach contents

    Time frame: Assessed at enrollment and during gastric ultrasound (within 3 hours of scheduled procedure).

  5. Differences in "high risk GLP-1" vs "low risk GLP-1"

    Time frame: assessed at time of enrollment from the past 30 days until completion of gastric ultrasound

    High Risk includes:

    • Escalation Phase: increase in dose within the past 30 days
    • High Dose
    • Weekly Dosing
    • Presence of severe GI symptoms such as nausea, vomiting, or retching, abdominal bloating, or abdominal pain with GLP-1 administration

    Low dose and high dose are classified as:

    Oral Semaglutide (Rybelsus) Low dose: < 5 mg High dose: > 5 mg

    Tirzepatide (Mounjaro and Zepbound) Low dose: 2.5, 5, and 7.5 mg High dose: 10, 12.5, 15 mg

    SubQ Semaglutide (Ozempic and Wegovy) Low dose: 0.25 and 0.5 mg High dose: 1 and 2 mg

    Dulaglutide (Trulicity) Low dose: 0.75 and 1.5 mg High dose: 3.0 and 4.5 mg

    Liraglutide (Victoza) Low dose: 0.6 mg High dose: 1.2 and 1.8 mg

    Exenatide (Byetta) Low dose: 5 mcg High dose: 10 mcg

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

An Observational Study to Examine Non-inferiority of the Standard ASA Fasting Guidelines Versus 24-hour Clear Liquid Diet for Gastric Volume in Patients Taking GLP-1 Agonists

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Feb 25, 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.