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临床试验/NCT03252405
NCT03252405已完成不适用

the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy

Ahi Evran University Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2017年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
2
主要终点
assess changing in pediatric agitation/ emergence delirium scale(PAED) scores

研究概览

简要总结

To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy

详细描述

Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation

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 (Investigator, Outcomes Assessor)

盲法说明

double blind

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

  • pediatric adenotonsillectomy

排除标准

  • patients with neurological, hepatic, renal disorders and using any drugs

研究组 & 干预措施

mask ventilation

Active Comparator

induction is made with mask ventilation

干预措施: mask ventilation (Device)

mask ventilation

Active Comparator

induction is made with mask ventilation

干预措施: intravenous cannulation (Device)

intravenous induction

Experimental

induction is made with intravenous cannulation

干预措施: intravenous cannulation (Device)

结局指标

主要结局

assess changing in pediatric agitation/ emergence delirium scale(PAED) scores

时间窗: postoperative first hour

to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.

次要结局

  • FLACC (face, legs,activity, cry, consolobility)(postoperative first hour)

研究者

发起方
Ahi Evran University Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevser Peker

MD

Ahi Evran University Education and Research Hospital

研究点 (2)

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