Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists

NCT ID: NCT06003985

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-29

Study Completion Date

2025-02-01

Brief Summary

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The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who take glucagon-like peptide 1 (GLP-1) agonist medications compared to patients who do not take GLP-1 agonists.

Detailed Description

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Glucagon-like peptide 1 (GLP-1) agonists have existed since 2005, however the newer once-weekly injectable medications particularly semaglutide, and tirzepatide have exploded in popularity due to their weight loss potential.

Anesthesiologists nationally have seen an increase in perioperative complications amongst patients taking these medications due to delayed gastric emptying increasing the risk of aspiration in the perioperative period. At HSS the majority of our anesthetics are done under sedation and therefore would not protect the patient from aspiration in the event of vomiting.

Protecting patients from aspiration secondary to vomiting during induction or maintenance of anesthesia has always been an important goal to make anesthesia safer leading to the development of NPO guidelines which are intended to protect against the presence of gastric content during anesthetic care. However there is growing concern that patients taking GLP-1 agonists may not be adequately protected using the current nothing by mouth or "NPO" guidelines. Up to this day there is no literature on how much gastric emptying is delayed during the use of GLP1 following the standard NPO guidelines.

Recently Gastric Ultrasound (GUS) has been introduced as a bedside tool for assessing a patients stomach contents and for the risk of aspiration. Gastric ultrasound can identify an empty stomach, a stomach filled with clear liquids, thick liquids or solid food content. If a stomach has clear liquid the volume can be calculated accurately. Generally a stomach with solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight is considered a full stomach. As GUS is noninvasive and well tolerated, it offers the perfect solution to assessing patient risk in the preoperative period.

Conditions

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Gastric Ultrasound Glucagon-like Peptide 1 Point of Care Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

The control group will be comprised of patients who are not currently taking any GLP-1 agonist medications. Controls will receive the ultrasound exam to assess stomach contents.

Gastric Ultrasound Exam

Intervention Type OTHER

A gastric ultrasound is a simple, fast, non-invasive bedside diagnostic test that provides a qualitative and quantitative assessment of gastric contents. There are no known risks of a gastric ultrasound exam.

GLP-1 agonist intake

The GLP-1 agonist intake group will be comprised of patients who are currently taking any GLP-1 agonist medications. This group will receive the ultrasound exam to assess stomach contents.

Gastric Ultrasound Exam

Intervention Type OTHER

A gastric ultrasound is a simple, fast, non-invasive bedside diagnostic test that provides a qualitative and quantitative assessment of gastric contents. There are no known risks of a gastric ultrasound exam.

Interventions

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Gastric Ultrasound Exam

A gastric ultrasound is a simple, fast, non-invasive bedside diagnostic test that provides a qualitative and quantitative assessment of gastric contents. There are no known risks of a gastric ultrasound exam.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* GLP 1 patient group: any patient on GLP1 agonists that are dosed once per week (semaglutide, dulaglutide, tirzepatide), for all indications.
* Control group (No GLP 1 patients): any patient not on GLP1 agonists that are dosed once per week, for all indications.

Exclusion Criteria

* patient refusal to participate
* patients with gastric bypass or any other gastric surgery
* large hiatal hernia
* patients with large ascites
* patients on peritoneal dialysis
* emergency surgery
* pre-existing diagnosis of gastroparesis
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Panzer, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, Department of Anesthesiology

Locations

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George Washington University Hospital

Washington D.C., District of Columbia, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.

Reference Type BACKGROUND
PMID: 36870274 (View on PubMed)

Maselli DB, Camilleri M. Effects of GLP-1 and Its Analogs on Gastric Physiology in Diabetes Mellitus and Obesity. Adv Exp Med Biol. 2021;1307:171-192. doi: 10.1007/5584_2020_496.

Reference Type BACKGROUND
PMID: 32077010 (View on PubMed)

Nakatani Y, Maeda M, Matsumura M, Shimizu R, Banba N, Aso Y, Yasu T, Harasawa H. Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy. Diabetes Metab. 2017 Oct;43(5):430-437. doi: 10.1016/j.diabet.2017.05.009. Epub 2017 Jun 23.

Reference Type BACKGROUND
PMID: 28648835 (View on PubMed)

Other Identifiers

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2023-0867

Identifier Type: -

Identifier Source: org_study_id

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