Effects of GLP-1 Agonists on Gastric Volume

Completed

• Conditions: Diabetes; Gastric Content Aspiration; Glucagon-like Peptide 1; GLP-1
• Interventions: Diagnostic Test: Gastric Ultrasound

• Registration Number: NCT05854979
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-11
• Study Start: 2023-08-09
• Status Verified: 2024-04
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetics taking a GLP-1 receptor agonist	Gastric Ultrasound	-
Diabetics not taking a GLP-1 receptor agonist (control)	Gastric Ultrasound	-

Primary Outcome Measures

Name	Time	Method
Gastric Volume in RLD Position	From time of enrollment until the start of surgery, assessed up to 4 weeks	The gastric volume will be calculated using a validated formula.

Secondary Outcome Measures

Name	Time	Method
Perlas antral grade	From time of enrollment until the start of surgery, assessed up to 4 weeks
Incidence of aspiration	From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
Gastric antrum CSA in RLD position	From time of enrollment until the start of surgery, assessed up to 4 weeks

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States