跳至主要内容
临床试验/NCT03330613
NCT03330613Unknown不适用

Emergence Delirium and Recovery Time in Children: a Randomized Trial to Compare Total Intravenous Anesthesia With Propofol to Inhalational Sevoflurane Anesthesia for Ambulatory Dental Surgery

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Emergence delirium

研究概览

简要总结

In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia.

详细描述

Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • •Indication of dental treatment under general anesthesia.
  • •No systemic disease (ASA1).
  • •Child and parent agree to participate in the work

排除标准

  • •Do not accept to participate in the work.
  • •The child is not systemically healthy.
  • •Children with allergies to general anesthetic drugs.
  • •Contraindicated children to take general anesthesia
  • •Children with upper respiratory tract infection on the day of operation

研究组 & 干预措施

Inhalational anesthesia

Other

Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.

干预措施: PAEDS (Diagnostic Test)

Inhalational anesthesia

Other

Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.

干预措施: TIVA (Procedure)

Inhalational anesthesia

Other

Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients.

干预措施: Inhalational anesthesia (Procedure)

Total intravenous anesthesia

Active Comparator

Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.

干预措施: PAEDS (Diagnostic Test)

Total intravenous anesthesia

Active Comparator

Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.

干预措施: TIVA (Procedure)

Total intravenous anesthesia

Active Comparator

Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients.

干预措施: Inhalational anesthesia (Procedure)

结局指标

主要结局

Emergence delirium

时间窗: 6 hours

Pediatric Anesthesia Early Delirium Scale (PAED) will be used to assess postoperative agitation. Point Description Not at all Just a little Quite a bit Very much Extremely 1. The child makes eye contact with the caregiver 4 3 2 1 0 2. The child's actions are purposeful 4 3 2 1 0 3. The child is aware of his/her surroundings 4 3 2 1 0 4. The child is restless 0 1 2 3 4 5. The child is inconsolable 0 1 2 3 4 The Pediatric Anesthesia Emergence Delirium Scale

次要结局

  • Recovery time(6 hours)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozlem Kocaturk

Asist.Prof. MD

Aydin Adnan Menderes University

研究点 (1)

Loading locations...

相似试验