Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor Agonist Prior to Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Number of participants that show prevalence of increased RGC determined using preoperative GUS
研究概览
简要总结
The purpose of this study is to determine if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and symptoms of nausea, vomiting, retching, abdominal bloating, and abdominal pain are present on the day of surgery, to see if there is any variability between preoperative gastric ultrasound assessment and volume of gastric contents visualized on upper endoscopy, to determine time of gastric emptying by serial Gastric ultrasonography (GUS) scans every 2 hours in subjects who presented with an initial at-risk scan, to determine the choice of anesthesia used based on preoperative GUS results, to determine if there were any adverse events recorded in this study group, to determine if duration of GLP-1 RA therapy has an association with residual gastric content (RGC). and to determine if dosing of GLP-1 RA has an association with RGC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
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 taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
- •Undergoing upper endoscopy only - no colonoscopy due to prep
排除标准
- •Previous gastric resection or bypass
- •Gastric band in situ
- •Previous fundoplication
- •Large hiatal hernia
- •Pregnant patients
- •Recent trauma
- •Inability to turn to the right lateral decubitus position.
- •Patients on erythromycin, metoclopramide, domperidone, opioids.
- •Gastroparesis previous
研究组 & 干预措施
GLP-1 RA users with standard NPO instructions
干预措施: GLP-1 RA users with standard NPO instructions (Other)
GLP-1 RA users with prolonged fasting instructions
干预措施: GLP-1 RA users with prolonged fasting instructions (Other)
结局指标
主要结局
Number of participants that show prevalence of increased RGC determined using preoperative GUS
时间窗: prior to procedure ( within 2 hours before procedure)
Participants with increased RGC will have solids, thick fluid, or clear fluids \>1.5ml/kg in the gastric antrum in the right lateral decubitus position
次要结局
- Number of participants that show thirst as assessed by the VAS(prior to procedure ( within 2 hours before procedure))
- Number of participants that show hunger as assessed by the VAS(prior to procedure ( within 2 hours before procedure))
- Number of participants that show anxiety as assessed by the VAS(prior to procedure ( within 2 hours before procedure))
研究者
Sudipta Sen
Associate Professor
The University of Texas Health Science Center, Houston
