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

NCT06659159 | Not Yet Recruiting

• 2 other identifiers: Effects of beginning a GLP1Hirslanden Klinik
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Aspiration During Anaesthetic Induction

Keywords

Pulmonary aspiration; Gastric ultrasound; GLP-1; Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Gastric content

  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

  baseline 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

Secondary Outcomes (8)

• Gastric emptying time

  baseline 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

• Number of empty stomachs

  baseline 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

• BMI

  baseline 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

• Gallbladder stones

  baseline 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

• Co-morbidities

  At the baseline examination at the first endocrinologic appointment

Study Arms (1)

GLP-1, New Therapy

Indication, prescription and dosage is determined independently of the study by the endocrinologist/obesity specialist, who is also part of the study team. Since the first gastric ultrasound will take place directly before the initiation of the GLP-1 Agonist therapy, the patients will serve as their own control group/baseline.

Diagnostic Test: Gastric ultrasound

Interventions

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.

GLP-1, New Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GLP-1 Therapy

You may qualify if:

• Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Sascha Battig: lead

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med.

CONTACT

+41 44 387 38 80; Michael.Ganter@hirslanden.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Michael Ganter

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 26, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share