NCT03130010已完成不适用
The Effect of Nefopam on Catheter-related Bladder Discomfort: A Double-blind, Randomized, Controlled, Parallel Design Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- catheter-related bladder discomfort
研究概览
简要总结
In the present study, the investigators evaluated whether nefopam 20 mg reduce the catheter-related bladder discomfort in patients undergoing foley catheter insertion
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to insert the catheter a new foley catheter more than 14 Fr in the operation site,
- •Adults 20 to 75years of age
- •American Society of Anesthesiologists Physical Classification 1,2 patients
- •Patients who pre-agreed to the study
- •Male patient
排除标准
- •Neurogenic bladder
- •Patients diagnosed with irritable bladder
- •study drug sensitive or contraindicated
- •Patients with central nervous system or neurological disorder (epilepsy, patients receiving MAO inhibitor)
- •Patients with urethral and prostate disorders
- •Patients with previous history of myocardial infarction
- •Patients with closed angle glaucoma
研究组 & 干预措施
The control group
Placebo Comparator
One hour before the end of the operation, the control group was received 20 ml of saline.
干预措施: Nefopam or saline (Drug)
The Nefopam group
Active Comparator
One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam.
干预措施: Nefopam or saline (Drug)
结局指标
主要结局
catheter-related bladder discomfort
时间窗: postoperative 1 hour
assessment of catheter-related bladder discomfort using visual analogue scale
次要结局
未报告次要终点
研究者
研究点 (1)
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