Improving Patient Safety for Surgical Patients on Semaglutide: A Gastric Ultrasound Initiative
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of full stomach.
研究概览
简要总结
The primary goal of this study is to evaluate the incidence of "full stomach" in fasting elective surgical patients on Semaglutide medication. The other goals are to study the impact of the time interval since the last dose of the medication on the incidence of full stomach and to develop evidence-based recommendations for the perioperative management of these patients.
详细描述
Pulmonary aspiration of gastric contents has long been recognized as a threat to anesthesia patient safety. Most elective surgical patients, however, are considered to be at low risk for this complication provided they abstain from eating solid food for at least 8 hours prior to anesthesia and for clear fluids for at least 2 hours. The recent introduction of GLP-1 agonists (such as Semaglutide), a new class of drugs for the treatment of diabetes and weight loss, has challenged the status quo, and is posing a new threat to perioperative patient safety.There are recent reports of aspiration of large amounts of particulate undigested food in the perioperative period on patients taking Semaglutide despite prolonged fasting of over 12 hours, one of those cases happening at the UHN.This is of great concern given the explosive increase in use of these medications globally.In the month of June 2023, three North American anesthesiology societies (the Canadian Anesthesiologists' Society, the American Society of Anesthesiologists and the Anesthesia Patient Safety Foundation) have raised the alert regarding an increased risk of aspiration under anesthesia while on these drugs.Given the long half-life of up to 7 days, a true reduction of risk would necessitate holding these drugs preoperatively for longer periods than are usually feasible.
Management strategies recommended to date include treating every patient on Semaglutide as if they have a 'full stomach", avoiding general anesthesia if possible and even considering surgical cancellation if the patient presents symptoms such as nausea and vomiting, which are common while on these medications. While these recommendations stand to reason, they are over-arching, targeted to all patients and could result in unnecessary surgical cancellations or invasive procedures (such as nasogastric tube insertion, endotracheal intubation and rapid sequence induction) which have their own set of risks.
This timely study addresses the current knowledge gap and a recently identified threat to perioperative patient safety that has been highlighted by three major anesthesiology societies in the past 2-3 months. Our team at the UHN is uniquely positioned to shed some light into these pressing questions and develop management recommendations that optimize safety while avoiding unnecessary surgical cancellations and targeting invasive procedures for airway management only to those patients that really need them.
Our group has previously developed and validated a simple, non-invasive bedside ultrasound test that can differentiate a safe "empty stomach" from a "full stomach" that may pose an increased risk of aspiration under anesthesia. The investigators have validated this bedside test in the adult, pediatric, obstetric and morbidly obese populations.
Hypothesis:
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
- •Patients scheduled for elective surgery at Toronto Western Hospital
- •Aged ≥ 18 years of age
- •American Society of Anaesthesia physical status classification I to III
- •Patients being treated with Semaglutide for at least 1 month
排除标准
- •Current pregnancy evidenced by positive urinary pregnancy test
- •Previous surgery of the upper gastrointestinal tract
结局指标
主要结局
Incidence of full stomach.
时间窗: Pre-Surgical fasting duration per guideline
Frequency of full stomach in patients taking semaglutide and fasting before surgery. Analysis of the primary outcome will be based on a chi-square analysis.
次要结局
- Any changes in anesthetic management from the a priori plan following the result of the gastric ultrasound examination.(Pre-operative anesthesia management plan)
- Impact of age, sex and the time since the last dose of Semaglutide, on the incidence of "full stomach".(Pre-Surgical fasting duration per guideline)
