Mitigating Harm: Assessing Preoperative Residual Gastric Volumes to Risk Stratify Patients Administering Semaglutide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Number of participants presenting with a full stomach
研究概览
简要总结
Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.
To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.
Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide.
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
- •all elective surgical patients (> 18 years of age)
- •followed institutional fasting protocol for surgery
- •patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
- •patients not taking GLP-1 receptor agonist (N =45)
排除标准
- •confounding delayed gastric emptying due to pregnancy
- •previous esophageal or gastric operation
- •etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
- •on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)
研究组 & 干预措施
GLP-1 Agonist Group
Intervention: elective surgical patients taking GLP-1 receptor agonists
干预措施: gastric antral sonography (Device)
Non GLP-1 Agonist Group
Intervention: elective surgical patients not taking GLP-1 receptor agonists
干预措施: gastric antral sonography (Device)
结局指标
主要结局
Number of participants presenting with a full stomach
时间窗: Measured in the preoperative holding area
Full stomach defined as either clear fluid \> 1.5ml/kg or solid content found with point-of-care gastric antral sonography.
次要结局
- Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration(Measured in the preoperative holding area)
- Number of occurrences requiring change in anesthetic management plan(From time of preoperative ultrasound in holding area to anesthesia induction in operating room)
- Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume(Measured in the preoperative holding area)
研究者
Joanna Moser
Clinical Assistant Professor
University of Calgary