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临床试验/NCT06814080
NCT06814080招募中不适用

Residual Gastric Content and GLP-1

University of Arkansas1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年5月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Prevalence of full stomach or residual gastric content in the 3 groups

研究概览

简要总结

Studies have shown that even following the fasting guideline, patients on GLP-1 still have residual gastric content which increases their risk of aspiration during anesthesia. We aim to investigate the prevalence of full stomachs following different fasting times.

详细描述

Glucagon-like peptide-1 (GLP-1) receptor agonists have become increasingly popular as both diabetic and weight loss therapies. One effect of this class of medication is delayed gastric emptying, which may impact the risk of aspiration during anesthesia delivery. Some of them have a very long half-life of approximately one week. Thus, it takes approximately five weeks to achieve its steady-state concentration, and just as long for its effects to terminate after stopping the drug.

As a standard of care, patients are allowed to drink up to 2 hours and to eat up to 8 hours before surgery. Studies have shown that even following the fasting guideline, patients still have residual gastric content which increases their risk of aspiration during anesthesia. Since stopping these drugs for a long time is not practical as it is going to disrupt their glycemic control and reverse the weight loss, we propose to test extending the fasting time.

We aim to investigate the prevalence of full stomachs following different fasting times.

patients will be assigned to one of three groups: Group 1(G1) with 8-hour fasting, Group 2 (G2) with 10-hour fasting, and Group 3 (G3) groups with 12-hour fasting

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 yr. ASA physical status I- III Elective surgery

排除标准

  • Pregnancy
  • History of upper gastrointestinal disease or previous surgery on the esophagus, stomach or upper abdomen;
  • Documented abnormalities of the upper gastrointestinal tract such as gastric tumors; recent upper gastrointestinal bleeding (within the preceding 1 month).
  • Medicines that may delay gastric emptying (e.g., anticholinergic agents, opioid)
  • ASA class IV or above
  • Unable to understand English
  • Cardiac cases with low ejection fraction
  • Elderly patients above 65 years of age
  • Liver or renal transplant cases
  • Type 1 diabetes Patients on insulin or sulphonylurea medication

结局指标

主要结局

Prevalence of full stomach or residual gastric content in the 3 groups

时间窗: 12 hours

Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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