Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSascha Battig
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
Signed informed consent
Disqualifiers
Known pregnancy, known lactation
Underage (< 18 years)
Absence of informed consent (missing or inability to provide)
Anomalies of the gastrointestinal tract
Trial population
GLP-1 Therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gastric ultrasound
Diagnostic testThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: GLP-1, New Therapy1 intervention
Trial outcomes
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
Time frame
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 startSecondary outcomes
1
Gastric emptying time
Sonographic measurement of gastric emptying time for 500ml of water before and during GLP-1 therapy. Gastric emptying time is measured with a continuous ultrasound examination. The variable of interest is once again the CSA of the gastric antrum and the time until the baseline from before water consumption is reached once again.
Time frame
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 start2
Number of empty stomachs
Absolute number of empty stomachs after adhering to standardised perioperative fasting intervals (6 hours for solids and 2 hours for liquids) before and once (if therapy is continued: twice) during GLP-1 Agonist therapy
Time frame
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 start3
BMI
Demographic data of the patient: BMI
Time frame
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 start4
Gallbladder stones
Presence of gallbladder stones (cholecystolithiasis)
Time frame
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 startLocations
Sponsors and contacts
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Sascha Battig
Lead sponsor
Klinik Hirslanden, Zurich
Sponsor institution
Source ClinicalTrials.gov
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