临床试验/NCT02576340

NCT02576340已完成4 期

Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial

Konya Meram State Hospital0 个研究点目标入组 400 人开始时间: 2013年1月最近更新: 2015年10月15日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Konya Meram State Hospital
入组人数: 400
主要终点: motility

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase the tolerability and compliance of the patient, sedation is applied. There are many studies showing that sedation increases the patient compliance and the tolerability. However, spasmolytic use in GE has not been evaluated yet.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•no hypersensitivity to the agent.

排除标准

•Emergent cases,the cases with low mental compatibility and pregnant women were excluded from the study. Moreover, the procedures under sedation, cases with disorders decreasing the intestinal motility like hypothyroidism and diabetes were excluded.

研究组 & 干预措施

study

Active Comparator

drug was administered

干预措施: otilonium bromide (Drug)

结局指标

主要结局

motility

时间窗: 3 months

decrease in motility during the procedure (number of peristaltic moves in a minute)

次要结局

patient tolerance(3 months)

研究者

发起方

Konya Meram State Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

barış sevinç

M. D.

Konya Meram State Hospital

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