- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003985
Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists
Assessment of Preoperative Gastric Content With Ultrasound in Patients Taking GLP1 Agonists
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
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-
-
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District of Columbia
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Washington D.C., District of Columbia, United States, 20037
- George Washington University Hospital
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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New York
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Albany, New York, United States, 12208
- Albany Medical Center
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New York, New York, United States, 10065
- Weill Cornell Medicine
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10021
- Hospital for Special Surgery
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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incidence of delayed gastric emptying
Time Frame: This will be measured pre-operatively in the holding room area.
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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.
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This will be measured pre-operatively in the holding room area.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Nothing by mouth (NPO) intervals
Time Frame: This will be measured pre-operatively in the holding room area.
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Measure the NPO interval after last solid, liquids, and clears precisely for a subgroup analysis.
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This will be measured pre-operatively in the holding room area.
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Presence of gastric peristalsis
Time Frame: This will be measured pre-operatively in the holding room area.
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Gastric peristalsis will be graded as present/ absent on gastric ultrasound
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This will be measured pre-operatively in the holding room area.
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Collaborators and Investigators
Investigators
- Principal Investigator: Oliver Panzer, MD, Hospital for Special Surgery, Department of Anesthesiology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-0867
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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