The RESIDUAL Study : Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery: a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Increased residual gastric content
研究概览
简要总结
Glucagon-like peptide-1 agonists (GLP-1RA) are a family of medications used for diabetes and weight loss. One of their effect is to slow down stomach emptying. The goal of this study is to evaluate the effect of GLP-1RA on the effectiveness of fasting before a scheduled surgery.
The question it aims to answer is: does this kind of medication increase the risk of having food or too much liquid in the stomach before a scheduled surgery, even if the minimum 6 hour fast is done?
For this project, researchers will use gastric ultrasound to compare participants already taking one of these medications as part of their home treatment to participants who are not taking them. Gastric ultrasound is a simple bedside exam using an echography machine that takes less than 5 minutes to do.
Participants will:
-Have a gastric ultrasound performed on them before their surgery
详细描述
Background: Glucagon-like peptide-1 receptor agonists (GLP-1RA) are glucose-lowering drugs that act through three mechanisms: stimulation of insulin secretion, inhibition of glucagon secretion and decrease of gastric emptying. The GLP-1RA are now an important part of glycemic control in type 2 diabetes mellitus (T2DM). Recently, GLP-1 RA have received approval for weight loss, expanding their use in overweight or obese non-diabetic patients.The effect of GLP-1RA on decreased gastric emptying has long been established but he clinical implication of this in the periprocedural setting is uncertain. Recent guidelines recommend holding the weekly-dosed for at least a week before elective surgery. Considering the extended half-lives of once-weekly GLP-1RA (approximately 6 days for semaglutide and 5 days for dulaglutide), it is unclear if following those guidelines is sufficient to make sure patients are not at high risk of aspiration
Hypothesis: This study will compare ultrasound-assessed residual gastric content (RGC) between once-weekly GLP-1RA users that stopped their medication for 7 days or more before elective surgery and patients not taking GLP-1RA. The investigators hypothesized that even with appropriate holding of GLP-1RA, those patients may have increased RGC and be at higher risk of aspiration.
Objectives:
Primary objective:
• To investigate the relation between GLP-1RA use and increased RGC
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •American Society of Anesthesiologists (ASA) class 1-4 patients
- •Age ≥ 18 years old
- •Fasted state (2 hours for clear liquids, 6 hours for solids)
- •Elective surgery
- •Last dose of once-weekly semaglutide or dulaglutide 7 days or more before surgery (for GLP-1RA group)
排除标准
- •Last dose of GLP-1RA less than 7 days before surgery
- •Inability to lay on the right-side for ultrasound
- •Pregnancy
- •History of gastric surgery or large hiatal hernia
研究组 & 干预措施
GLP-1RA agonists users
Participants presenting for elective surgery and taking once-weekly semaglutide or dulaglutide as part of their usual treatment with the last dose at least 7 days before surgery
干预措施: Gastric ultrasound (Diagnostic Test)
Control group
Participants presenting for elective surgery and not taking semaglutide or dulaglutide
干预措施: Gastric ultrasound (Diagnostic Test)
结局指标
主要结局
Increased residual gastric content
时间窗: Preoperative (day of surgery)
The primary endpoint will be the prevalence of increased residual gastric content defined by the presence of any of the following: * Solid or thick fluid content on gastric ultrasound * Content of more than 1.5 mL/kg of clear fluids on gastric ultrasound using the following formula : Gastric volume (mL) = 27 + \[14.6 × right lateral cross-sectional area (in cm2)\] - \[1.28 × age (in years)\]
次要结局
未报告次要终点