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临床试验/NCT06154486
NCT06154486已完成不适用

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

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
prevalence of full stomach after fasting for at least 8 hours

研究概览

简要总结

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.

详细描述

INTRODUCTION

Obesity and type 2 diabetes mellitus constitute a global public health problem. Medications with glucagon-like peptide-1(GLP-1) receptor agonist action are a modern therapeutic option for both diseases. Liraglutide, semaglutide and dulaglutide are some representatives of this drug class, whose mechanism of action results in slowing gastric emptying, reduced gastric motility, and increased gastric volume These effects are implicated in both weight loss and the occurrence of adverse events such as nausea, vomiting, acute gastroparesis and gastroesophageal reflux disease (GERD) The presence of gastric contents during the anesthetic procedure can lead to pulmonary aspiration and the development of chemical pneumonitis, a potentially fatal complication. To avoid this risk, in healthy patients, an 8-hour fast for solids and 2 hours for clear liquids. However, when there is a risk factor for slow gastric emptying, despite adequate fasting, the stomach may present residues and bedside ultrasound is an effective, non-invasive and quickly to measure this content and stratify the risk of aspiration Due to the lack of studies demonstrating that the use of GLP-1 analogue can increase the risk of aspiration in individuals who are fasting adequately to receive anesthesia, there is no formal recommendation for performing gastric ultrasound in the preoperative period, nor for the suspension of these medications. Some institutions empirically recommend suspension preoperatively.

Given the severity of the occurrence of bronchoaspiration, the biological action of GLP-1 analogues on gastric function and the incremental use of these medications, it is necessary to better understand the gastric contents of individuals fasting and using a GLP-1 analogue. GLP-1. Thus, through 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 fasting recommended for this purpose and are using semaglutide, a GLP-1 analogue.

Our hypothesis is that the majority of individuals using these medications have a full stomach even with the fasting times recommended in the literature. In view of this, for this population we must adapt safety criteria during the anesthetic procedure.

Objectives Primary objective The primary objective is to evaluate the prevalence of a full stomach through gastric ultrasound examination in volunteers who use semaglutide and are fasting for at least 8 hours for solids and 2 hours for clear liquids. As a control group, we will use volunteers who do not use semaglutide.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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.

排除标准

  • 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.

研究组 & 干预措施

semaglutide group

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

干预措施: semaglutide use (Drug)

结局指标

主要结局

prevalence of full stomach after fasting for at least 8 hours

时间窗: 1 day

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.

次要结局

  • Incidence of symptoms associated with medication use(1 day)
  • demographic distribution(1 day)
  • medication information(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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