Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists

ConditionsResidual Gastric Contents Pulmonary Aspiration of Gastric Contents

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSt Vincent's Hospital Melbourne

About this trial

The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on:

* Solid content or thick fluids * Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety. * Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids.

We will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old at enrolment.

Have regularly administered any type of once-weekly GLP-1 RA medication for a period of at least one month prior to randomisation.

If allocated to follow standard fasting guidelines, willing to adhere to ASA and ANZCA preoperative fasting requirements. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.

If allocated to follow a 24-hour clear liquid diet, willing to adhere to nothing-by-mouth (NPO) for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.

Disqualifiers

Has a recent history of gastrointestinal bleed within the previous 1 month from enrolment.

Has a history of previous lower oesophageal or gastric surgery.

Has a known abnormal upper gastrointestinal anatomy, including hiatus hernia or gastric tumours.

Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.

Trial design

Design model

Parallel

Treatments tested in this trial

24-hour clear liquid diet
Other intervention
Participants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
Standard fasting guidelines
Other intervention
Participants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.

Treatment groups

154 Participants

are divided into 2 treatment groups

Group A: 24-hour clear liquid dietExperimental treatment 1 intervention

Group B: Standard fasting guidelinesActive comparator 1 intervention

Trial outcomes

Primary outcomes

Residual gastric contents

Difference in proportion of participants who present with increased residual gastric contents, defined as \>1.5mL/kg of clear fluids, thick fluids or solids, as assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues.

Time frame