NCT06003985

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

August 29, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

August 15, 2023

Last Update Submit

November 19, 2025

Conditions

Gastric UltrasoundGlucagon-like Peptide 1Point of Care Ultrasound

Keywords

GLP1gastric ultrasound

Outcome Measures

Primary Outcomes (1)

  • incidence of delayed gastric emptying

    delayed gastric emptying is defined by the presence of either solid food, thick liquids or a specific volume (\>1.5 ml/kg) of clear liquids on gastric ultrasound.

    This will be measured pre-operatively in the holding room area.

Secondary Outcomes (2)

  • Nothing by mouth (NPO) intervals

    This will be measured pre-operatively in the holding room area.

  • Presence of gastric peristalsis

    This will be measured pre-operatively in the holding room area.

Study Arms (2)

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.

Other: 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.

Other: Gastric Ultrasound Exam

Interventions

Gastric Ultrasound ExamOTHER

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.

ControlGLP-1 agonist intake

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be comprised of patients scheduled for surgery at HSS who meet the following inclusion criteria and none of the exclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (3)

  • 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.

    PMID: 36870274BACKGROUND

  • 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.

    PMID: 32077010BACKGROUND

  • 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.

    PMID: 28648835BACKGROUND

Study Officials

  • Oliver Panzer, MD

    Hospital for Special Surgery, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

August 29, 2023

Primary Completion

January 31, 2025

Study Completion

February 1, 2025

Last Updated

November 26, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(7)