跳至主要内容
临床试验/NCT01353378
NCT01353378撤回4 期

Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
post anesthesia emergence delirium scale(PAED scale)

研究概览

简要总结

The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.

详细描述

Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • preschool children undergoing oral maxillofacial surgery

排除标准

  • mental diseases
  • history of neural system disease
  • sedative medication history
  • anticipated difficult airway

研究组 & 干预措施

dexmedetomidine

Experimental

intravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively.

干预措施: dexmedetomidine (Drug)

结局指标

主要结局

post anesthesia emergence delirium scale(PAED scale)

时间窗: 2 hours post-surgery

evaluate children's PAED scale score 2 hours post-surgery

次要结局

  • Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale)(2 hours post-surgery)

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rong Hu

attending in anesthesiology department

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

研究点 (1)

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