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临床试验/NCT02228473
NCT02228473Unknown不适用

Effect of Glycopyrrolate and Atropine as Adjuncts to Reversal of Non-Depolarizing Neuromuscular Blocking Agents on Postoperative Catheter-Related Bladder Discomfort

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
76
试验地点
1
主要终点
Catheter-related bladder discomfort

研究概览

简要总结

We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.

详细描述

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. The adjuncts to reversal agents such as glycopyrrolate and atropine are known to block the muscarinic receptor in different ways.

We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention 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
Triple (Participant, Investigator, Outcomes Assessor)

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 excision under general anesthesia
  • ASA I-III

排除标准

  • Foley catheter less than 18 Fr.
  • Patients with obstruction of urinary tract
  • Patients with neurogenic bladder
  • Patients with severe obesity
  • Patients with neurologic disorder
  • Patients with chronic pain
  • Patients with allergic history to atropine or glycopyrrolate

研究组 & 干预措施

Glycopyrrolate

Experimental

Glycopyrrolate will be administered as the adjuncts of neuromuscular blocker reversal agent.

干预措施: Glycopyrrolate (Drug)

Atropine

Active Comparator

Atropine will be administered as the adjuncts of neuromuscular blocker reversal agent.

干预措施: Atropine (Drug)

结局指标

主要结局

Catheter-related bladder discomfort

时间窗: 1 hour postoperatively

Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).

次要结局

  • Hemodynamic parameters(0, 1, 5, 10 minute postoperatively)
  • Nausea(0, 1, 6 and 24 hour postoperatively)
  • Vomiting(0, 1, 6 and 24 hour postoperatively)
  • Blurred vision(0, 1, 6 and 24 hour postoperatively)
  • Flushing(0, 1, 6 and 24 hour postoperatively)
  • Dizziness(0, 1, 6 and 24 hour postoperatively)
  • Analgesics(0, 1, 6 and 24 hour postoperatively)
  • Catheter-related bladder discomfort(0, 6 and 24 hour postoperatively)
  • Dry mouth(0, 1, 6 and 24 hour postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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