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临床试验/NCT04583111
NCT04583111Unknown4 期

The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
200
试验地点
1
主要终点
Incidence of the discomforts during bowel preparation

研究概览

简要总结

Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.

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
Single (Outcomes Assessor)

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

  • 18-70 years patients scheduled for colonoscopy

排除标准

  • intestinal obstruction or hemorrhage;
  • allergy to domperidone, sulpiride or PEG;
  • pregnancy or breastfeeding;
  • previous use of prokinetics within 1 month.

研究组 & 干预措施

Domperidone group

Experimental

Patients in Domperidone group took 10mg of domperidone 30min before PEG.

干预措施: Domperidone (Drug)

Sulpiride group

Experimental

Patients in Sulpiride group took 100mg of sulpiride 30min before PEG.

干预措施: sulpiride (Drug)

结局指标

主要结局

Incidence of the discomforts during bowel preparation

时间窗: before colonoscopy

The primary endpoint of this study was the discomforts during bowel preparation such as nausea, vomit, abdominal fullness and pain. These symptoms were assessed as none, mild, moderate and severe. Patients with mild to severe symptoms were classified as presence of discomforts.

次要结局

  • The quality of bowel preparation assessed by Boston Bowel Preparation Scale(during colonoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shengliang Chen

Deputy director of the Division of Gastroenterology and Hepatology

RenJi Hospital

研究点 (1)

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