A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups
研究概览
简要总结
To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- Patients must be 18 years or older as well as willing and able to provide informed consent
- •Patients undergoing a scheduled gynecologic procedure with cystoscopy
排除标准
- •- Patients are younger than 18 years
- •Patients are unable or unwilling to provide informed consent
- •Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine
- •Patients with a history of renal insufficiency
- •Patients with a history of liver disease
- •Patients with a history of sickle cell disease
- •Patients with a history of glucose-6-phosphate dehydrogenase deficiency
- •Patients with a history of chronic obstructive pulmonary disease or currently being treated for asthma
研究组 & 干预措施
Sodium Fluorescein
Patients will receive an intravenous dose of 0.25 mL of 10% (500 mg, 5 mL) sodium fluorescein at the time of cystoscope insertion, for a total dose of 25 mg. Cystoscopy will be performed in the standard fashion during the course of the operation.
干预措施: sodium fluorescein (Drug)
oral phenazopyridine
Patients randomized to the phenazopyridine arm will be given a 200 mg pill with a sip of water in the pre-operative area 1 hour before their scheduled procedure. Cystoscopy will be performed in the standard fashion during the course of the operation.
干预措施: phenazopyridine (Drug)
结局指标
主要结局
differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups
时间窗: 12 months
次要结局
- number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0(12 months)