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临床试验/NCT05013320
NCT05013320撤回不适用

Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery

Kangbuk Samsung Hospital0 个研究点开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
The incidence of catheter-related bladder discomfort

研究概览

简要总结

Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status I and II
  • elective transurethral resection of bladder tumor under general anesthesia

排除标准

  • arrhythmia
  • bladder outflow obstruction
  • overacitve bladder
  • end stage renal disease
  • neurogenic bladder
  • morbid obesity
  • psychiatric disorder

研究组 & 干预措施

Dexmedetomidine only

Active Comparator

dexmedetomidine is administered during the surgery

干预措施: Dexmedetomidine (Drug)

Combined dexmedetomidine and glycopyrrolate

Experimental

glycopyrrolate and dexmedetomidine are administered during the surgery

干预措施: Glycopyrrolate + dexmedetomidine (Drug)

结局指标

主要结局

The incidence of catheter-related bladder discomfort

时间窗: 0 minute after entering the post-anesthetic care unit

No = not complaining of bladder discomfort on asking; Mild = report discomfot only on questioning; Moderate: report without questioning without behavior responses; Severe = report without questioniing accompanied by behavior responses. Mild, Moderate, Severe bladder discomfort is defined to have catheter-related bladder discomfort

次要结局

  • Sedation score(0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit)
  • Dry mouth(0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit)
  • postoperative nausea and vomiting(0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit)
  • Emergence agitation(0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit)
  • Delirium(0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit)
  • Postoperative pain(0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eunah Cho, MD

Assistant professor

Kangbuk Samsung Hospital

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