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Trial · Observational

CompletedPhase not statedRegistry data

Evaluation of Gastric Content of Volunteers Fasting and Using Semaglutide: an Observational and Cross-sectional Study

Overview

Status
Completed
Phase
Phase not stated
Enrollment
30 participants (actual)
Sponsor
Hospital Israelita Albert Einstein · Other
Design
Not stated
Countries
1 country

Brazil

Start
19 Jun 2023
Primary completion
19 Jun 2023
Completion
22 Aug 2023
First posted
4 Dec 2023
Last update posted
4 Dec 2023
Conditions
Pneumonia, Aspiration · Anesthesia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph –

    Evaluation of Gastric Content of Volunteers Fasting and Using Semaglutide: an Observational and Cross-sectional Study

    NCT06154486

    19 Jun 2023 to 22 Aug 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Medicines with peptide-1 receptor agonist action similar to glucagon (GLP-1) are a modern therapeutic option for obesity and diabetes mellitus. Semaglutide is a representative of this class medication whose mechanism of action can result in the slowing of gastric emptying and reduced gastric motility, a scenario that can increase the risk of pulmonary aspiration in individuals undergoing anesthesia and despite adequate fasting. Given the severity of the occurrence of bronchoaspiration, the action biological analysis of GLP-1 analogues on gastric function and incremental use of these medications, through gastric ultrasound, we will aim to evaluate the gastric contents of volunteers who do not have risk factors for bronchoaspiration, who will not undergo anesthesia, but are with the fasting recommended for this purpose and are using semaglutide, an analogue of GLP-1. Our hypothesis is that the majority of individuals using these medications have a full stomach even during fasting times recommended in the literature. In view of this, for this population we must adapt safety criteria during the anesthetic procedure.

Interventions

  • semaglutide useDrug

Arms2

  • Other

    semaglutide group

    patients without risk factors for gastroparesis, fasting for at least 8 hours, BMI less than 30 and currently using semaglutide

  • Other

    control group

    patients without risk factors for gastroparesis, fasting for at least 8 hours, BMI less than 30 and who have never used semaglutide or another GLP-1 analogue

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. prevalence of full stomach after fasting for at least 8 hours

    Time frame · 1 day

    Registry description

    Compare the prevalence of a full stomach, after fasting for at least 8 hours for solids and 2 hours for clear liquids, through gastric ultrasound in volunteers using semaglutide with those who do not use the medication. The outcome will be binary: a full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg. It will be considered an empty stomach when no content or clear liquids are visible inferior to 1.5ml/kg.

Secondary outcomes(3)
  1. demographic distribution

    Time frame · 1 day

    Registry description

    • Assess the demographic characteristics

  2. medication information

    Time frame · 1 day

    Registry description

    Describe the dose and regimen of medication use and reason for using the medication.

  3. Incidence of symptoms associated with medication use

    Time frame · 1 day

    Registry description

    Describe the presence of symptoms such as nausea, vomiting and sensation of gastric fullness, loss of appetite, early satiety and abdominal pain

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Case report · 2020

1 result

Gastroparesis With the Initiation of Liraglutide: A Case Report.

Almustanyir et al. 2020Cureuscited by 6

PMID 33403167PMC7773310DOI 10.7759/cureus.11735PUB-33403167

CC BY1 result

Indexing hint: Randomized controlled trial · 2017

11 results

Effects of liraglutide on weight, satiation, and gastric functions in obesity: a randomised, placebo-controlled pilot trial.

Halawi et al. 2017The lancet. Gastroenterology & hepatologycited by 180

PMID 28958851DOI 10.1016/s2468-1253(17)30285-6PUB-28958851

Full text at the publisher11 results

More studies

1 study on this page

Indexing hint: Review · 2021

Contemporary Classification of Glucagon-Like Peptide 1 Receptor Agonists (GLP1RAs).

Kalra et al. 2021Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 32

PMID 34268675PMC8342688DOI 10.1007/s13300-021-01113-yPUB-34268675

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not stated
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * • Adult individuals (aged 18 or over). * Individuals currently using semaglutide. * Individuals fasting for at least 8 hours for solids and 2 hours for clear liquids without residue. Exclusion Criteria: * Pregnant women and postpartum women. * Individuals with technical limitations to perform gastric content assessment using ultrasonography * Presence of risk factors for gastroparesis. * Use of drugs from the prokinetic class, which accelerate gastric emptying, such as bromopride, metoclopramide and domperidone.

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