Time-dependent Association Between Cessation of Glucagon-like Peptide-1 Receptor Agonists and Residual Gastric Contents Assessed by Point-of-care Gastric Ultrasound: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
研究概览
简要总结
This prospective observational study will evaluate the association between the time interval since the last dose of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and residual gastric contents before elective surgery. Adult patients receiving GLP-1 RAs and scheduled for elective non-cardiac surgery under general anesthesia will undergo preoperative point-of-care gastric ultrasound. The study will assess whether longer GLP-1 RA cessation intervals are associated with lower ultrasound-estimated gastric volume and a lower frequency of high-risk gastric contents. Body mass index will also be evaluated as a potential modifier of this association.
详细描述
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly used for the treatment of type 2 diabetes and obesity. These agents can delay gastric emptying, raising concerns about residual gastric contents and potential aspiration risk during anesthesia. Current perioperative recommendations regarding GLP-1 RA discontinuation are largely consensus-based, and the physiological relationship between cessation interval and residual gastric content remains insufficiently defined.
This single-center prospective observational cohort study will enroll adult patients who are receiving GLP-1 RAs and are scheduled for elective non-cardiac surgery requiring general anesthesia. GLP-1 RA management will follow usual clinical care; the study team will not assign, modify, or instruct the timing of drug discontinuation. The primary exposure will be the number of days since the last GLP-1 RA dose, analyzed both as a continuous variable and according to prespecified cessation-interval categories.
Immediately before induction of anesthesia, participants will undergo standardized point-of-care gastric ultrasound. Qualitative gastric content will be assessed using the Perlas grading system, and quantitative gastric volume will be estimated from the antral cross-sectional area measured in the right lateral decubitus position. The primary outcome will be estimated gastric volume normalized to body weight. Secondary outcomes will include antral cross-sectional area, Perlas grade, and the presence of high-risk gastric contents.
Multivariable regression models will be used to evaluate the association between GLP-1 RA cessation interval and gastric ultrasound findings after adjustment for clinically relevant covariates, including age, sex, body mass index, diabetes status, preoperative fasting duration, and gastrointestinal symptom score. Body mass index will be evaluated as a prespecified effect modifier.
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
- 19 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Patients receiving a glucagon-like peptide-1 receptor agonist.
- •Patients scheduled for elective non-cardiac surgery requiring general anesthesia.
- •Patients able to provide written informed consent.
排除标准
- •Emergency surgery.
- •History of prior gastric surgery.
- •Known gastroparesis or severe gastroesophageal reflux disease.
- •Declined or unable to provide written informed consent.
研究组 & 干预措施
Last GLP-1 RA Dose 8 Days or More
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 8 days or more before elective surgery. No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care. Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
干预措施: GLP-1 RA Cessation Interval (Other)
Last GLP-1 RA Dose 3 Days or Less
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 3 days or less before elective surgery. No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care. Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
干预措施: GLP-1 RA Cessation Interval (Other)
Last GLP-1 RA Dose 4 to 7 Days
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 4 to 7 days before elective surgery. No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care. Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
干预措施: GLP-1 RA Cessation Interval (Other)
研究者
Cheol Lee,MD,PhD,
Professor
Wonkwang University Hospital
