Gastric Content in Fasting Volunteers and in Tirzepatide Users: an Observational and Cross-sectional Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasonographic evaluation of gastric content

    Other intervention

    Ultrasonographic evaluation of gastric content

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: fasting tirzepatide users1 intervention
Group B: fasting volunteers.1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day

Secondary outcomes

1

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

Time frame
1 day

Other outcomes

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