Role of Diphenhydramine in Prevention of Catheter Related Bladder Discomfort
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- incidence of catheter related bladder discomfort postoperative
研究概览
简要总结
Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male patients aged more than18-80 years ASA I and II , upper ureteric stone removal under general anesthesia r
排除标准
- •overactive bladder cognitive impairment a neuropsychological disorder, bladder outflow obstruction urinary tract infection, , neurogenic bladder, operative time > 6 h
研究组 & 干预措施
Diphenhydramine group
干预措施: DiphenhydrAMINE 50 Mg/mL Injectable Solution (Drug)
control group
干预措施: Saline (Drug)
结局指标
主要结局
incidence of catheter related bladder discomfort postoperative
时间窗: UP TO 6 HOURE
* none, did not complain of any CRBD even upon asking. * mild, revealed only on questioning. * moderate, reported without questioning but not accompanied by any behavioral response. * severe, stated on their own and followed by behavioral responses such as a strong verbal response, flailing limbs, and even attempting to pull out the urinary catheter
次要结局
- visual analog scale (VAS)(up to 6 hours)
研究者
Amr Samir Wahdan
Assistant Professor
Cairo University