跳至主要内容
临床试验/NCT00785889
NCT00785889已完成不适用

A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.

East Bay Institute for Research and Education2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2008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
56
试验地点
2
主要终点
Increments of medications used for sedation

研究概览

简要总结

Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

详细描述

Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.

Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients.

Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.

Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.

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
Single (Participant)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy individual 50 years or older
  • eligible for colorectal cancer screening or surveillance

排除标准

  • patients who do not understand or failed to sign informed consent

结局指标

主要结局

Increments of medications used for sedation

时间窗: duration of procedure

次要结局

  • pain scores during colonoscopy(duration of procedure)
  • success with cecal intubation(during procedure)
  • willingness to repeat colonoscopy(after procedure)

研究者

发起方
East Bay Institute for Research and Education
申办方类型
Other

研究点 (2)

Loading locations...

相似试验