About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
Undergoing upper endoscopy only - no colonoscopy due to prep
Disqualifiers
Previous gastric resection or bypass
Gastric band in situ
Previous fundoplication
Large hiatal hernia
Trial design
Parallel
Treatments tested in this trial
GLP-1 RA users with prolonged fasting instructions
Other interventionNPO 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 standard NPO instructions
Other interventionNPO 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
Sponsors and contacts
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