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临床试验/NCT06003985
NCT06003985已完成不适用

Assessment of Preoperative Gastric Content With Ultrasound in Patients Taking GLP1 Agonists

Hospital for Special Surgery, New York8 个研究点 分布在 2 个国家目标入组 354 人开始时间: 2023年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
354
试验地点
8
主要终点
incidence of delayed gastric emptying

研究概览

简要总结

The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who take glucagon-like peptide 1 (GLP-1) agonist medications compared to patients who do not take GLP-1 agonists.

详细描述

Glucagon-like peptide 1 (GLP-1) agonists have existed since 2005, however the newer once-weekly injectable medications particularly semaglutide, and tirzepatide have exploded in popularity due to their weight loss potential.

Anesthesiologists nationally have seen an increase in perioperative complications amongst patients taking these medications due to delayed gastric emptying increasing the risk of aspiration in the perioperative period. At HSS the majority of our anesthetics are done under sedation and therefore would not protect the patient from aspiration in the event of vomiting.

Protecting patients from aspiration secondary to vomiting during induction or maintenance of anesthesia has always been an important goal to make anesthesia safer leading to the development of NPO guidelines which are intended to protect against the presence of gastric content during anesthetic care. However there is growing concern that patients taking GLP-1 agonists may not be adequately protected using the current nothing by mouth or "NPO" guidelines. Up to this day there is no literature on how much gastric emptying is delayed during the use of GLP1 following the standard NPO guidelines.

Recently Gastric Ultrasound (GUS) has been introduced as a bedside tool for assessing a patients stomach contents and for the risk of aspiration. Gastric ultrasound can identify an empty stomach, a stomach filled with clear liquids, thick liquids or solid food content. If a stomach has clear liquid the volume can be calculated accurately. Generally a stomach with solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight is considered a full stomach. As GUS is noninvasive and well tolerated, it offers the perfect solution to assessing patient risk in the preoperative period.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • GLP 1 patient group: any patient on GLP1 agonists that are dosed once per week (semaglutide, dulaglutide, tirzepatide), for all indications.
  • Control group (No GLP 1 patients): any patient not on GLP1 agonists that are dosed once per week, for all indications.

排除标准

  • patient refusal to participate
  • patients with gastric bypass or any other gastric surgery
  • large hiatal hernia
  • patients with large ascites
  • patients on peritoneal dialysis
  • emergency surgery
  • pre-existing diagnosis of gastroparesis

结局指标

主要结局

incidence of delayed gastric emptying

时间窗: This will be measured pre-operatively in the holding room area.

delayed gastric emptying is defined by the presence of either solid food, thick liquids or a specific volume (\>1.5 ml/kg) of clear liquids on gastric ultrasound.

次要结局

  • Presence of gastric peristalsis(This will be measured pre-operatively in the holding room area.)
  • Nothing by mouth (NPO) intervals(This will be measured pre-operatively in the holding room area.)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (8)

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