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临床试验/NCT03955926
NCT03955926已完成不适用

Ultrasonographic Assessment of Stomach for Comparison of Antral Cross-sectional Area in Two Different Fasting Guidelines

Eunah Cho, MD2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Cross-sectional area of gastric antrum

研究概览

简要总结

Oral carbohydrate loading until 2 h before surgery is well known to be effective in facilitating postoperative recovery and reducing complications, by maintaining homeostasis. However, there are still concerns in implementing this as a universal fasting guideline, because of the risk of pulmonary aspiration. Therefore, we designed this study to compare the two preoperative fasting guideline: (1) keep fasted from midnight until surgery, and (2) oral carbohydrate beverage 800 mL from midnight until 2 h before surgery.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • adult aged from 18 to 70
  • American Society of Anesthesiologists (ASA) class I or II
  • absence of pregnancy
  • not on lactation at the time of surgery

排除标准

  • delayed gastric emptying (GERD, gastrointestinal disease, diabetes)
  • contraindicated to NSAID or opioid
  • mental disorders
  • alcoholism
  • drug abuse

结局指标

主要结局

Cross-sectional area of gastric antrum

时间窗: 1 hour before surgery

Cross-sectional area of gastric antrum assessed by ultrasonography

次要结局

  • Hunger score(1 hour before surgery)
  • Preoperative anxiety(1 hour before surgery)
  • Thirst score(1 hour before surgery)

研究者

发起方
Eunah Cho, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eunah Cho, MD

Clinical Assistant Professor

Kangbuk Samsung Hospital

研究点 (2)

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