About this trial
Introduction
Obesity and type 2 diabetes mellitus constitute a global public health problem. Medications with glucagon-like peptide-1 (GLP-1) receptor agonist activity are a modern therapeutic option for both diseases. Liraglutide, semaglutide, dulaglutide and tirzepatide are representatives of this drug class, whose mechanism of action results in delayed gastric emptying, reduced gastric motility and increased gastric volume.
Tirzepatide, however, presents a dual agonist action, combining GLP-1 agonism with glucose-dependent insulinotropic polypeptide (GIP) agonism.
The presence of gastric content during anaesthesia may lead to pulmonary aspiration and the development of chemical pneumonitis, a potentially devastating complication. However, when there is a risk factor for delayed gastric emptying, despite adequate fasting, the stomach may still present residual content, and bedside ultrasonography is an effective, non-invasive and rapid method to measure this content and stratify aspiration risk.
Our hypothesis is that most individuals using tirzepatide present a full stomach even after fasting times recommended in the literature.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 years or older.
Individuals currently using tirzepatide.
Individuals fasting for at least 8 hours for solids and 2 hours for clear liquids without residue.
Disqualifiers
Pregnant or postpartum individuals.
Technical limitation for gastric ultrasound assessment.
Presence of risk factors for gastroparesis.
Use of prokinetic medications such as bromopride, metoclopramide or domperidone.
Trial population
Thirty volunteers will be included, of whom 15 will be current users of tirzepatide and 15 will not be using the medication.
Trial design
Other
Prospective
Treatments tested in this trial
Ultrasonographic evaluation of gastric content
Other interventionUltrasonographic evaluation of gastric content
Treatment groups
Trial outcomes
Primary outcomes
Comparison of the prevalence of a full stomach after fasting using gastric ultrasonography in volunteers using tirzepatide versus those not using the medication.
Comparison of the prevalence of a full stomach after fasting using gastric ultrasonography in volunteers using tirzepatide versus those not using the medication. The outcome is binary: a full stomach is defined as the presence of solids or clear liquid volume greater than 1.5 mL/kg.
Secondary outcomes
demographic characteristics
* Demographic characteristics * Dose and dosing regimen * Indication for medication use * Presence of symptoms (nausea, vomiting, gastric fullness, early satiety, abdominal pain) * Use of other medications
Sponsors and contacts
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