Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) Agonist Prior to Anesthesia

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Aspiration

• Registration Number: NCT06654219
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to determine if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and symptoms of nausea, vomiting, retching, abdominal bloating, and abdominal pain are present on the day of surgery, to see if there is any variability between preoperative gastric ultrasound assessment and volume of gastric contents visualized on upper endoscopy, to determine time of gastric emptying by serial Gastric ultrasonography (GUS) scans every 2 hours in subjects who presented with an initial at-risk scan, to determine the choice of anesthesia used based on preoperative GUS results, to determine if there were any adverse events recorded in this study group, to determine if duration of GLP-1 RA therapy has an association with residual gastric content (RGC). and to determine if dosing of GLP-1 RA has an association with RGC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Study Start: 2025-04-15
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
• Undergoing upper endoscopy only - no colonoscopy due to prep

Exclusion Criteria

• Previous gastric resection or bypass
• Gastric band in situ
• Previous fundoplication
• Large hiatal hernia
• Pregnant patients
• Recent trauma
• Inability to turn to the right lateral decubitus position.
• Patients on erythromycin, metoclopramide, domperidone, opioids.
• Gastroparesis previous

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants that show prevalence of increased RGC determined using preoperative GUS	prior to procedure ( within 2 hours before procedure)	Participants with increased RGC will have solids, thick fluid, or clear fluids \>1.5ml/kg in the gastric antrum in the right lateral decubitus position

Secondary Outcome Measures

Name	Time	Method
Number of participants that show thirst as assessed by the VAS	prior to procedure ( within 2 hours before procedure)	This is measured in a linear scale from 1-10, higher number showing worse outcome
Number of participants that show hunger as assessed by the VAS	prior to procedure ( within 2 hours before procedure)	This is measured in a linear scale from 1-10, higher number showing worse outcome
Number of participants that show anxiety as assessed by the VAS	prior to procedure ( within 2 hours before procedure)	This is measured in a linear scale from 1-10, higher number showing worse outcome

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States