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临床试验/NCT02960412
NCT02960412已完成4 期

Randomized Controlled Trial Evaluating Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

University of South Florida1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年5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
状态
已完成
入组人数
150
试验地点
1
主要终点
time to ureteral patency

研究概览

简要总结

This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery.

详细描述

Cystoscopy is performed routinely after urogynecologic surgery to ensure there was no injury to the urinary tract (urethra, bladder, or ureters). In order to confirm that no damage occurred to the ureters, a jet of urine must be visualized from each ureteral opening.

The time it takes to confirm this ureteral patency is variable and some sources suggest using furosemide to decrease the time it takes to see these jets. This study will evaluate what effect, if any, this medicine has on time to confirming ureteral patency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Undergoing any urogynecologic surgery
  • No allergy or contraindication to receiving furosemide
  • Normal Creatinine/glomerular filtration rate

排除标准

  • Unable to consent, including if non English speaking
  • Allergy or contraindication to receiving furosemide
  • Intraoperative injury to the lower urinary tract

研究组 & 干预措施

furosemide

Experimental

furosemide 10mg (1mL) IV push for one dose

干预措施: furosemide (Drug)

placebo

Placebo Comparator

normal saline 1mL IV push for one dose

干预措施: Normal Saline (Drug)

结局指标

主要结局

time to ureteral patency

时间窗: intra-operative

time to confirmation of ureteral patency in seconds

次要结局

  • adverse effects from furosemide administration(immediately post operative (1-3 days post operatively))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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