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临床试验/NCT02428283
NCT02428283已完成4 期

The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年5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
已完成
发起方
入组人数
44
试验地点
1
主要终点
change of Watcha behavior scale for emergence agitation (4 point)

研究概览

简要总结

Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.

详细描述

Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled. Anesthesia was induced with thiopental sodium and rocuronium, and maintained with sevoflurane. Patients were randomly assigned two groups: the control group received IV remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine 2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and Watcha behavior scale for emergence agitation were assessed.

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, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I-II patients undergoing general anesthesia for nevus surgery

排除标准

  • developmental disorder
  • neurologic disorder
  • coaguloparthy
  • allergy to local anesthetics

研究组 & 干预措施

Nerve block

Experimental

Scalp nerve block was performed with 0.25% ropivacaine.

干预措施: Ropivacaine (Drug)

Nerve block

Experimental

Scalp nerve block was performed with 0.25% ropivacaine.

干预措施: Sevoflurane (Drug)

Control

Active Comparator

Remifentanil was administered intravenously.

干预措施: Remifentanil (Drug)

Control

Active Comparator

Remifentanil was administered intravenously.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

change of Watcha behavior scale for emergence agitation (4 point)

时间窗: from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Yeop Kim

Associate professor

Ajou University School of Medicine

研究点 (1)

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