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临床试验/NCT01492296
NCT01492296已完成不适用

Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours

Universidade de Passo Fundo1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2011年3月1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
115
试验地点
1
主要终点
safety

研究概览

简要总结

Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty stomach is required to ensure quality and safety. For this reason, endoscopy is conventionally performed after 8 or more hours of fasting, which is potentially related to discomfort to the patients. In recent studies, surgical cholecystectomy has been described to be safe after two hours of fasting on liquids. The aim of this study is to assess safety, quality and comfort of upper GI endoscopy after two hours of fasting.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective endoscopy

排除标准

  • poor clinical condition

结局指标

主要结局

safety

时间窗: 10 min (endoscopy duration)

safety of endoscopy after fasting for two hours will be assessed by means of a questionnaire replied by the endoscopists, questioning occurrence of aspiration and regurgitation of gastric contents into the esophagus.

次要结局

  • quality(10 min (endoscopy duration))
  • Endoscopy comfort(8 hours)

研究者

发起方
Universidade de Passo Fundo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Fornari

Clinical Professor

Universidade de Passo Fundo

研究点 (1)

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