Residual Gastric Content and GLP-1

Studies have shown that even following the fasting guideline, patients on GLP-1 still have residual gastric content which increases their risk of aspiration during anesthesia. We aim to investigate the prevalence of full stomachs following different fasting times.

Study Overview

• Status: Recruiting
• Conditions: Pre-op Gastric Emptying

Detailed Description

Glucagon-like peptide-1 (GLP-1) receptor agonists have become increasingly popular as both diabetic and weight loss therapies. One effect of this class of medication is delayed gastric emptying, which may impact the risk of aspiration during anesthesia delivery. Some of them have a very long half-life of approximately one week. Thus, it takes approximately five weeks to achieve its steady-state concentration, and just as long for its effects to terminate after stopping the drug.

As a standard of care, patients are allowed to drink up to 2 hours and to eat up to 8 hours before surgery. Studies have shown that even following the fasting guideline, patients still have residual gastric content which increases their risk of aspiration during anesthesia. Since stopping these drugs for a long time is not practical as it is going to disrupt their glycemic control and reverse the weight loss, we propose to test extending the fasting time.

We aim to investigate the prevalence of full stomachs following different fasting times.

patients will be assigned to one of three groups: Group 1(G1) with 8-hour fasting, Group 2 (G2) with 10-hour fasting, and Group 3 (G3) groups with 12-hour fasting

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Mohamed A Abdeldayem, MD; Email: MAAbdeldayem@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Science
      • Contact: Mohamed Abdeldayem, MD; Email: MAAbdeldayem@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All subjects on GLP-1 scheduled for elective surgery will be screened for recruitment. We will find prospective subjects via medical records review or through our preoperative evaluation team which is a standard of care and then contact the patients about the study. Subjects enrolled in the study will be treated as per normal practice for elective surgery.

Description

Inclusion Criteria:

Age ≥ 18 yr. ASA physical status I- III Elective surgery

Exclusion Criteria:

• Pregnancy
• History of upper gastrointestinal disease or previous surgery on the esophagus, stomach or upper abdomen;
• Documented abnormalities of the upper gastrointestinal tract such as gastric tumors; recent upper gastrointestinal bleeding (within the preceding 1 month).
• Medicines that may delay gastric emptying (e.g., anticholinergic agents, opioid)
• ASA class IV or above
• Unable to understand English
• Cardiac cases with low ejection fraction
• Elderly patients above 65 years of age
• Liver or renal transplant cases
• Type 1 diabetes Patients on insulin or sulphonylurea medication

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
8 hour fasting; A standardized gastric scanning protocol will be used, and patients classified following a 3-point grading system based solely on qualitative sonographic assessment of the antrum in the supine and right lateral decubitus positions. A qualitative assessment of the residual gastric fluid volume will be performed, according to the three-point grading scale previously described by Perlas et al. Grade 0 was defined by the absence of visualization of any content into a flat antrum in both the supine and the right lateral decubitus positions. Grade 1 was defined by the appearance of fluid content in the right lateral decubitus position only, and Grade 2 was defined by the visualization of fluid content in both the supine and the right lateral decubitus positions.
10 hour fasting; A standardized gastric scanning protocol will be used, and patients classified following a 3-point grading system based solely on qualitative sonographic assessment of the antrum in the supine and right lateral decubitus positions. A qualitative assessment of the residual gastric fluid volume will be performed, according to the three-point grading scale previously described by Perlas et al. Grade 0 was defined by the absence of visualization of any content into a flat antrum in both the supine and the right lateral decubitus positions. Grade 1 was defined by the appearance of fluid content in the right lateral decubitus position only, and Grade 2 was defined by the visualization of fluid content in both the supine and the right lateral decubitus positions.
12 hour fasting; A standardized gastric scanning protocol will be used, and patients classified following a 3-point grading system based solely on qualitative sonographic assessment of the antrum in the supine and right lateral decubitus positions. A qualitative assessment of the residual gastric fluid volume will be performed, according to the three-point grading scale previously described by Perlas et al. Grade 0 was defined by the absence of visualization of any content into a flat antrum in both the supine and the right lateral decubitus positions. Grade 1 was defined by the appearance of fluid content in the right lateral decubitus position only, and Grade 2 was defined by the visualization of fluid content in both the supine and the right lateral decubitus positions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of full stomach or residual gastric content in the 3 groups	Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.	8 hours
Prevalence of full stomach or residual gastric content in the 3 groups	Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.	10 hours
Prevalence of full stomach or residual gastric content in the 3 groups	Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.	12 hours

Collaborators and Investigators

• Sponsor: University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 287139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No