Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 75
- 主要终点
- Number of uncomplicated examinations
研究概览
简要总结
The primary objective is to investigate whether intake of approximately 200 ml of sugary fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of fasting period for patients without reducing the quality of the study.
Current standard for fasting and fluid intake before gastroscopy is completely fasting 6 hours before the study. Studies in patients in general anesthesia has been found that it does not increase the risk of aspiration of stomach content during the operation by allowing the patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have examined the quality gastroscopy using this fasting procedure. Some studies show that intake of sugary liquids do not have significant effect on gastric emptying.
There are not deemed to be ethical problems with this study, as it seeks to show that a more lenient standard procedure in endoscopy is as safe as the established. The study is considered safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
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
- •Age over 18 years
- •Sufficient knowledge of Danish to understand the written information
- •legally competent patients
排除标准
- •Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
- •Incapacitated patients
- •Patients with daily vomiting.
研究组 & 干预措施
Group 2
6 hours of total fast for all solid and liquid food / drinks
Group 1
- 6 hour fast from all solid foods and milk beverages
- 2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)
- Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.
干预措施: Group 1 (Behavioral)
结局指标
主要结局
Number of uncomplicated examinations
时间窗: participants will be followed for the duration of hospital stay, an expected average of 1 hour
次要结局
- Reduction of discomfort for the patients according to the survey.(participants will be followed for the duration of hospital stay, an expected average of 1 hour)
研究者
Anton Bilenko, MD
MD
Odense University Hospital