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临床试验/NCT03636828
NCT03636828Unknown不适用

Gastric Emptying Time of a Rice-based Meal Using Serial Sonographic Assessment

Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
ultrasonographic measurement of gastric antral cross-sectional area (CSA)

研究概览

简要总结

Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, but the emptying time of a rice-based meal (Asian foods) in healthy populations was not clear. The objective of this study was to investigate the minimum fasting time required for adequate gastric emptying after the ingestion of a rice-based meal.

详细描述

Aspiration of gastric contents into the lungs in surgical patients is a rare, but serious adverse event. Because a proper preoperative fasting is mandatory before anesthesia to prevent this severe complication, patients undergoing elective surgery have traditionally asked to fast overnight to ensure that their stomachs are empty. However, it is difficult and uncomfortable for patients not to eat or drink, particularly for those scheduled for surgery later in the day. Fasting may lead to thirst, hunger, anxiety, and tiredness, along with the potential for hypoglycemia and dehydration. Moreover, prolonged preoperative starvation triggers a metabolic response that precipitates gluconeogenesis and increases the organic response to trauma [7,8] and leads to delayed recovery after surgery. Avoiding inordinate fasting before surgery markedly reduces postoperative insulin resistance which has beneficial effects on postoperative glucose and protein metabolism.

Current guidelines by the American Society of Anesthesiologists (ASA) recommend a minimum of 6 hours after a light meal (toast and clear fluid) and 8 hours if the meal includes fried or fatty foods. In the era of evidence-based medicine, however, these fasting recommendations to keep a patient in preoperative fasting of 6-8 hours after the intake of solid meal are derived from survey opinions solicited from 470 active members of the ASA membership despite insufficient literature.

Recent studies have shown that real-time ultrasonography can provide reliable information about the nature (clear fluid, solid, or none) and volume of gastric content, being a non-invasive, inexpensive and safe method. The ultrasonographic measurement of antral cross-sectional area (CSA) is used for the assessment of gastric emptying in diabetic or dyspeptic patients and clinical investigations in obstetrical anesthesia. Thus, we designed this study to evaluate scientifically the gastric emptying time of solid meal using serial sonographic assessment in healthy volunteers. (Especially, there was no study to evaluate the gastric emptying time of a rice-based meal.) The objective of this study was to confirm or confront the minimum fasting time required for adequate gastric emptying for a rice-based meal (Asian foods), according to the suggestion of current guideline.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years old
  • body mass index between 18.5 and 29.9 kg/m2

排除标准

  • history of gastrointestinal disease such as history of surgery of upper abdomen, hiatal hernia and gastroesophageal reflux,
  • diabetes mellitus
  • chronic kidney disease
  • pregnancy

结局指标

主要结局

ultrasonographic measurement of gastric antral cross-sectional area (CSA)

时间窗: 8 hours after the ingestion of a sold meal

次要结局

未报告次要终点

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Taejong Song

Professor

Kangbuk Samsung Hospital

研究点 (1)

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