Clinical trial

Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying

Opening soon · Not applicable · 0 countries · Registry ID NCT06659159

Opening soonNot applicableObservational

What this study is about

This project explores the elevated risk of pulmonary aspiration during anesthesia in patients undergoing GLP-1 agonist therapy, which prolongs gastric emptying. Despite standard fasting guidelines (6 hours for solids, 2 hours for liquids), some patients still experience aspiration, indicating that GLP-1 therapy may heighten risk. The American Society of Anesthesiologists has advised pausing GLP-1 therapy before surgery, but this recommendation has faced criticism for being too broad. More data on this issue is needed, particularly concerning the effect of tachyphylaxis (reduced drug response over time) on gastric emptying. The study proposes using gastric ultrasound as a non-invasive tool to evaluate residual gastric content and categorize patients by their aspiration risk. The study will assess the stomach's content and gastric emptying time in patients both before and after starting GLP-1 therapy, comparing results under standard fasting conditions. The project is a national, single-center, prospective observational study targeting 50 patients, examining factors like patient demographics, GLP-1 therapy details, and gastrointestinal side effects. Data collection will occur through baseline and follow-up sonographic exams before and after therapy initiation. The study aims to improve perioperative management strategies by clarifying the risks associated with GLP-1 therapy

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionPulmonary Aspiration During Anaesthetic Induction

Full registry criteria

Inclusion Criteria: * Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist * Signed informed consent Exclusion Criteria: * Known pregnancy, known lactation * Underage (\< 18 years) * Absence of informed consent (missing or inability to provide) * Anomalies of the gastrointestinal tract * Known illnesses of the gastrointestinal tract * Previous surgery of the gastrointestinal tract * Elevated risk for hypoglycaemia (Sulfonylurea or Insulin) * No investigator with completed structural education in gastric sonography is available * Lack of intention to respect the fasting intervals and predefined standardised meals for the sonographic examination

Treatments and study arms

Gastric ultrasound

Diagnostic Test

The sequence in which the study is conducted will be as follows, the first examination (baseline examination) will take place immediately before the appointment and prescription of GLP-1 Analoga (before the first injection). During the examination the gastric content (quality/quantity) will be determined, secondly, a baseline for gastric emptying time after oral intake of 500ml of water is collected (patient drinks water, the stomach emptying will simultaneously be tracked with gastric ultrasound). In accordance with the first endocrinological control examination (6-8 weeks after therapy initiation) the same gastric ultrasound examination is performed.

Primary outcomes

Gastric contentbaseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start

Sonographic assessment of the gastric content (quality and quantity) after a standardised meal and regular perioperative fasting interval (at least 6 hours for solids and 2 hours for liquids) before initiation and once 6-8 weeks after GLP-1 therapy initiation

Study locations

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No public site location was included in this record. Check the original registry for updates.