Clinical trial NCT06654219: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Aspiration
Keywords: Glucagon Like Peptide-1 Receptor (GLP-1 RA)
full stomach
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants that show prevalence of increased RGC determined using preoperative GUS
timeFrame: prior to procedure ( within 2 hours before procedure)
Secondary outcomes:
measure: Number of participants that show thirst as assessed by the VAS
timeFrame: prior to procedure ( within 2 hours before procedure)
measure: Number of participants that show hunger as assessed by the VAS
timeFrame: prior to procedure ( within 2 hours before procedure)
measure: Number of participants that show anxiety as assessed by the VAS
timeFrame: prior to procedure ( within 2 hours before procedure)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sudipta Sen, MD, FASA
role: PRINCIPAL_INVESTIGATOR
References: