Residual Gastric Content and GLP-1

Not yet recruiting

• Conditions: Pre-op Gastric Emptying

• Registration Number: NCT06814080
• Lead Sponsor: University of Arkansas

Brief Summary

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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Study Start: 2025-05
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of full stomach or residual gastric content in the 3 groups	12 hours	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.

Trial Locations

Locations (1)

University of Arkansas for Medical Science; 🇺🇸 Little Rock, Arkansas, United States