NCT06839248

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

Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: St Vincent's Hospital Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

GLP-1 RAs have had a transformative impact on the management of obesity, cardiovascular disease, and type 2 diabetes. Despite this, this class of medications pose a significant challenge in the perioperative setting, as GLP-1 RAs are known to increase patients' risk of presenting to surgery with residual gastric contents even when standard fasting guidance is adhered to. Such residual contents pose a risk for devastating complications if they are aspirated during surgery. In procedures such as upper endoscopy, where clear visualisation of the gastric tract is essential, the presence of residual contents in the stomach may result in procedures being aborted, leading to patients being exposed to additional risks associated with having to repeat the procedure. Despite the urgent need for clear guidance based on reliable evidence, healthcare professionals are currently practicing in an almost complete absence of evidence regarding the management of GLP-1 RAs in the perioperative period. Our trial aims to address the uncertainty around pre-procedure management of patients using GLP-1 RAs by evaluating whether a 24-hour clear liquid diet can reduce the likelihood of increased residual gastric contents in patients using once-weekly GLP-1 RA medications, compared to the standard fasting guidelines currently recommended before elective procedures. Standard fasting guidelines, as defined by the ASA and ANZCA, recommend clear liquids up to 2 hours before anaesthesia, a light or low calorific meal up to 6 hours before anaesthesia, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to anaesthesia.The trial will also examine the effect of this more stringent fasting guidance on outcomes including thirst, hunger, nausea, fatigue, and anxiety, which impact both comfort and satisfaction among patients undergoing surgery.

Conditions

• Residual Gastric Contents
• Pulmonary Aspiration of Gastric Contents

Interventions

Type	Name	Description
OTHER	24-hour clear liquid diet	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.
OTHER	Standard fasting guidelines	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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-02-09
• Completion: 2026-02-09
• First posted: 2025-02-21
• Last updated: 2025-08-22

Locations

2 sites across 1 country: Australia