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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GLP-1 RA users with prolonged fasting instructions
  • Other: 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 Comparator
GLP-1 RA users with standard NPO instructions
  • Other: 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Contact:
Sudipta Sen, MD, FASA
(713) 500-6202
Sudipta.Sen@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Sudipta Sen, MD, FASA
(713) 500-6202
Sudipta.Sen@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.