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

The University of Texas System (UT)

Status: Enrolling

Conditions: Pulmonary Aspiration

Treatments: Other: GLP-1 RA users with standard NPO instructions; Other: GLP-1 RA users with prolonged fasting instructions

Study type: Interventional

Funder types: Other

Identifiers

NCT06654219

HSC-MS-24-0940

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

GLP-1 RA users with prolonged fasting instructions

Experimental group

Treatment:

Other: GLP-1 RA users with prolonged fasting instructions

GLP-1 RA users with standard NPO instructions

Active Comparator group

Treatment:

Other: GLP-1 RA users with standard NPO instructions