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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • GLP-1 RA users with prolonged fasting instructions

    Other intervention

    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.

  • GLP-1 RA users with standard NPO instructions

    Other intervention

    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.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: GLP-1 RA users with prolonged fasting instructionsExperimental treatment 1 intervention
Group B: GLP-1 RA users with standard NPO instructionsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
prior to procedure ( within 2 hours before procedure)

Secondary outcomes

1

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

Time frame
prior to procedure ( within 2 hours before procedure)
2

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

Time frame
prior to procedure ( within 2 hours before procedure)
3

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

Time frame
prior to procedure ( within 2 hours before procedure)

Other outcomes

Sponsors and contacts

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