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临床试验/NCT02181543
NCT02181543已完成3 期

Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

Professor Fernando Figueira Integral Medicine Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Postoperative agitation

研究概览

简要总结

The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.

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 (Investigator)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 2 - 12 Years.
  • Need for tonsillectomy / adenotonsillectomy.
  • Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or
  • Anestesia geral com sevoflurano.
  • Use of Intraoperative dipyrone, 30-50mg/Kg, IV.

排除标准

  • Changes in consciousness.
  • Neurological Deficit.
  • Use of another drug as medication before anesthesia.

研究组 & 干预措施

Clonidine

Experimental

Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative.

干预措施: Clonidine (Drug)

结局指标

主要结局

Postoperative agitation

时间窗: 6 hours

Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).

次要结局

  • Duration of postoperative agitation(6 hours)
  • Parental satisfaction.(24 hours)
  • Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters(6 hours)
  • Need for post-anesthetic drugs for treatment of agitation(6 hours)
  • Drowsiness(6 hours)

研究者

发起方
Professor Fernando Figueira Integral Medicine Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Sandro Rolland de Souza

Professor

Professor Fernando Figueira Integral Medicine Institute

研究点 (1)

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