Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying: a Prospective Ultrasound Approach with Focus on Perioperative Aspiration Risk.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Gastric content
研究概览
简要总结
This project explores the elevated risk of pulmonary aspiration during anesthesia in patients undergoing GLP-1 agonist therapy, which prolongs gastric emptying. Despite standard fasting guidelines (6 hours for solids, 2 hours for liquids), some patients still experience aspiration, indicating that GLP-1 therapy may heighten risk. The American Society of Anesthesiologists has advised pausing GLP-1 therapy before surgery, but this recommendation has faced criticism for being too broad. More data on this issue is needed, particularly concerning the effect of tachyphylaxis (reduced drug response over time) on gastric emptying.
The study proposes using gastric ultrasound as a non-invasive tool to evaluate residual gastric content and categorize patients by their aspiration risk. The study will assess the stomach's content and gastric emptying time in patients both before and after starting GLP-1 therapy, comparing results under standard fasting conditions.
The project is a national, single-center, prospective observational study targeting 50 patients, examining factors like patient demographics, GLP-1 therapy details, and gastrointestinal side effects. Data collection will occur through baseline and follow-up sonographic exams before and after therapy initiation. The study aims to improve perioperative management strategies by clarifying the risks associated with GLP-1 therapy
详细描述
This project investigates the risk of pulmonary aspiration during anesthesia in patients undergoing treatment with GLP-1 agonists, a class of medications that prolong gastric emptying and are commonly used for obesity and diabetes management. Pulmonary aspiration remains a significant cause of morbidity and mortality in anesthesia-related complications, and patients with delayed gastric emptying are at higher risk. Recent reports suggest that patients taking GLP-1 agonists may be at increased risk for aspiration, even when adhering to standard perioperative fasting guidelines (6 hours for solids, 2 hours for liquids).
The American Society of Anesthesiologists (ASA) has issued a warning about the potential risk of aspiration in patients on GLP-1 agonist therapy, recommending pausing the medication before surgery. However, this recommendation has been criticized for being too broad, given the lack of comprehensive data on the exact impact of GLP-1 agonists on gastric emptying and aspiration risk. Since many patients treated with GLP-1 agonists are already at higher risk of aspiration due to comorbidities like obesity and diabetes, understanding how this therapy further affects gastric function is crucial. There are also indications of a "tachyphylaxis" effect, where patients develop tolerance to the drug's impact over time, but its effect on gastric emptying and perioperative aspiration risk is not well understood.
Study Rationale and Objectives
The primary aim of this study is to assess whether patients undergoing GLP-1 agonist therapy have a higher likelihood of a full stomach after the recommended fasting intervals. Additionally, the study aims to evaluate the time taken for gastric emptying in these patients, focusing on the clearance of 500 ml of water.
Study Design
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
- 否
入选标准
- •Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
- •Signed informed consent
排除标准
- •Known pregnancy, known lactation
- •Underage (< 18 years)
- •Absence of informed consent (missing or inability to provide)
- •Anomalies of the gastrointestinal tract
- •Known illnesses of the gastrointestinal tract
- •Previous surgery of the gastrointestinal tract
- •Elevated risk for hypoglycaemia (Sulfonylurea or Insulin)
- •No investigator with completed structural education in gastric sonography is available
- •Lack of intention to respect the fasting intervals and predefined standardised meals for the sonographic examination
结局指标
主要结局
Gastric content
时间窗: baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start
Sonographic assessment of the gastric content (quality and quantity) after a standardised meal and regular perioperative fasting interval (at least 6 hours for solids and 2 hours for liquids) before initiation and once 6-8 weeks after GLP-1 therapy initiation
次要结局
- Gastric emptying time(baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start)
- Number of empty stomachs(baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start)
- BMI(baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start)
- Gallbladder stones(baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start)
- Co-morbidities(At the baseline examination at the first endocrinologic appointment)
- Side effects GLP-1(baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start)
- Discontinuation GLP-1(baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start)
- Co-medication(baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start)
研究者
Sascha Battig
Prof. Dr. med. Michael Ganter
Klinik Hirslanden, Zurich