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临床试验/NCT01991223
NCT01991223Unknown4 期

Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
114
试验地点
1
主要终点
The number of patients with catheter-related bladder discomfort

研究概览

简要总结

To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort

详细描述

After transurethral bladder resection, large-sized foley catheter have been used for drainage of urine and residual blood. Because of urinary catheterization, patients usually experiences catheter-related bladder discomfort defined as a burning sensation with an urge to void or discomfort in the supra-pubic region caused by catheter- related bladder irritation.

Dexmedetomidine is an alpha-2 antagonist and used as an analgesic agent. The investigators try to evaluate The efficacy of dexmedetomidine for the treatment of catheter-related bladder discomfort

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
Double (Participant, Care Provider)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for transurethral bladder resection
  • ASA I-III

排除标准

  • Patient who disagrees to participate this investigation
  • Patient with severe cardiovascular disease
  • Patient with small-sized foley catheter (less than 18 Fr.)
  • Patinets with any urinary tract obstructions
  • Patient with hyperactive or neurogenic bladder
  • Patients with chronic renal failure
  • Patient with morbidly obese
  • Patients with neurogenic disorder
  • Patient with medications for chronic pain

研究组 & 干预措施

Placebo group

Placebo Comparator

NS infusion will be done during surgery.

干预措施: NS infusion (Drug)

Dex group

Experimental

DEX infusion will be done during surgery.

干预措施: Dex infusion (Drug)

结局指标

主要结局

The number of patients with catheter-related bladder discomfort

时间窗: at postoperative 1 hour

catheter-related bladder discomfort at postoperative 1 hour was evaluated as none, mild, moderate, severe. The number of patients with mild, moderate, severe discomfort will be calculated and compared between groups.

次要结局

  • Catheter-related bladder discomfort(at postoperative 0, 1, 6, 24 hours)
  • Pain at suprapubic area(at postoperative 0, 1, 6, 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hee-Pyoung Park

Professor

Seoul National University Hospital

研究点 (1)

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