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Clinical Trial NCT06654219 for Pulmonary Aspiration is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 136 Dietary
Clinical Trial NCT06654219 is an interventional study for Pulmonary Aspiration that is recruiting. It started on October 30, 2025 with plans to enroll 136 participants. Led by The University of Texas Health Science Center, Houston, it is expected to complete by May 1, 2026. The latest data from ClinicalTrials.gov was last updated on November 3, 2025.
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...Show More
Official Title
Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor Agonist Prior to Anesthesia
Conditions
Pulmonary AspirationOther Study IDs
- HSC-MS-24-0940
NCT ID Number
Start Date (Actual)
2025-10-30
Last Update Posted
2025-11-03
Completion Date (Estimated)
2026-05-01
Enrollment (Estimated)
136
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Glucagon Like Peptide-1 Receptor (GLP-1 RA)
full stomach
full stomach
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGLP-1 RA users with prolonged fasting instructions | GLP-1 RA users with prolonged fasting instructions 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. |
Active ComparatorGLP-1 RA users with standard NPO instructions | GLP-1 RA users with standard NPO instructions 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of participants that show thirst as assessed by the VAS | This is measured in a linear scale from 1-10, higher number showing worse outcome | prior to procedure ( within 2 hours before procedure) |
Number of participants that show hunger as assessed by the VAS | This is measured in a linear scale from 1-10, higher number showing worse outcome | prior to procedure ( within 2 hours before procedure) |
Number of participants that show anxiety as assessed by the VAS | This is measured in a linear scale from 1-10, higher number showing worse outcome | prior to procedure ( within 2 hours before procedure) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
- Undergoing upper endoscopy only - no colonoscopy due to prep
- 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
The University of Texas Health Science Center, HoustonStudy Responsible Party
Sudipta Sen, Principal Investigator, Associate Professor, The University of Texas Health Science Center, Houston
Study Central Contact
Contact: Sudipta Sen, MD, FASA, (713) 500-6202, [email protected]
Contact: Paul Potnuru, (713) 500-6271, [email protected]
1 Study Locations in 1 Countries
Texas
The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States
Sudipta Sen, MD, FASA, Contact, (713) 500-6202, [email protected]
Paul Potnuru, Contact, (713) 500-6271, [email protected]
Recruiting