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

NCT06654219 | Recruiting

• 1 other identifier: HSC-MS-24-0940
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Aspiration

Keywords

Glucagon Like Peptide-1 Receptor (GLP-1 RA); full stomach

Outcome Measures

Primary Outcomes (1)

• Number of participants that show prevalence of increased RGC determined using preoperative GUS

  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

  prior to procedure ( within 2 hours before procedure)

Secondary Outcomes (3)

• Number of participants that show thirst as assessed by the VAS

  prior to procedure ( within 2 hours before procedure)

• Number of participants that show hunger as assessed by the VAS

  prior to procedure ( within 2 hours before procedure)

• Number of participants that show anxiety as assessed by the VAS

  prior to procedure ( within 2 hours before procedure)

Study Arms (2)

GLP-1 RA users with prolonged fasting instructions

EXPERIMENTAL

Other: GLP-1 RA users with prolonged fasting instructions

GLP-1 RA users with standard NPO instructions

ACTIVE COMPARATOR

Other: GLP-1 RA users with standard NPO instructions

Interventions

GLP-1 RA users with prolonged fasting instructions OTHER

NPO for solids: 24 hours prior to procedure, clear liquid diet (CLD) for 24 hours with last intake of clears no less than 2 hours prior to a procedure.GLP-1 RA will not be held prior to surgery and usual dosing schedule will be followed prior to procedure.

GLP-1 RA users with prolonged fasting instructions

GLP-1 RA users with standard NPO instructions OTHER

NPO after midnight prior to procedure; Minimum solid fasting duration of 8 hours for solids and 2 hours for liquids. Last dose of GLP-1 RA no less than 7 days prior to procedure.

GLP-1 RA users with standard NPO instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Sudipta Sen, MD, FASA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sudipta Sen, MD, FASA

CONTACT

(713) 500-6202; Sudipta.Sen@uth.tmc.edu

Paul Potnuru

CONTACT

(713) 500-6271; Paul.Potnuru@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: October 30, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)