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临床试验/NCT01322724
NCT01322724已完成不适用

Comparing Warm Versus Cool Temperature Water During Colonoscopy

OHSU Knight Cancer Institute1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
1
主要终点
Dose of sedation medication used (fentanyl and midazolam)

研究概览

简要总结

The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening

排除标准

  • •Patients undergoing colonoscopy for any other indication besides colon cancer screening
  • •Patients with prior colonic resections
  • •Patients with chronic narcotic or benzodiazepine use
  • •Poor bowel preparation (i.e. Boston bowel preparation score < 8)
  • •Patients with obstructing colonic lesions detected on colonoscopy

研究组 & 干预措施

Warm water

Active Comparator

Body temperature (95-100 degrees F) water

干预措施: Warm vs Cool water (Procedure)

Cool water

Experimental

Room temperature (68-73 degrees F) water

干预措施: Warm vs Cool water (Procedure)

结局指标

主要结局

Dose of sedation medication used (fentanyl and midazolam)

时间窗: Duration of the colonoscopy; Up to 3 hours

次要结局

  • Patient pain/discomfort score(During the day of the procedure; Up to 1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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