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临床试验/NCT02707016
NCT02707016Unknown不适用

Emergence Delirium in Children: a Randomized Clinical Trial of Different Doses of Sevoflurane During Induction of Anesthesia

Pontificia Universidad Catolica de Chile2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Emergence delirium

研究概览

简要总结

The investigators aim to reduce the incidence of emergence delirium in children aged 2-7 years old by using two different doses of sevoflurane during inhalatory induction of anesthesia.

详细描述

Sevoflurane is an inhalational agent widely used in general anesthesia, both for induction and maintenance of anesthesia. It is not irritative on the airways and has a pleasant smell. Within their properties are: low partition coefficient blood / gas (rapid induction and awakening), low heart, liver and kidney toxicity. Inhalational induction in pediatric anesthesia with this agent is frequent to avoid vein puncture in awake patients and is generally done with maximum doses available to obtain a fast loss of consciousness.

Emergence delirium (ED) is frequent in children. It is defined as a mental disorder during recovery from general anesthesia that may include hallucinations, delusions and confusion expressed by crying, restlessness and involuntary physical activity. It usually lasts for 30 minutes and is not necessarily related to pain. During this episodes, children can hurt themselves or others, lose vascular catheters or other invasive devices. ED can generate anxiety and stress in caretakers, delay transfer from Post-Anesthesia Care Units (PACU), increase costs of medical attention and increase use of opioids or other sedatives.

Many interventions have been used to decrease the appearance of ED such as dexmedetomidine, clonidine, benzodiazepines, propofol among others but with no consistent results. The use of sevoflurane has been linked with ED in children and it can induce seizures in high doses (over 2 MAC).

The aim of this study is to test whether using a lower dose of sevoflurane (5%) during induction of anesthesia in children results in less ED than using higher doses (8%).

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Surgery with caudal block: circumcision (phimosis), hernioplasty (inguinal hernia)
  • American Society of Anesthesiologists (ASA) classification of I or II

排除标准

  • Use of Total Intravenous Anesthesia (TIVA)
  • Familiar or personal history of Malignant Hyperthermia
  • Contraindication to caudal block
  • Parents or legal guardians do not sign informed consent

结局指标

主要结局

Emergence delirium

时间窗: From end of gas administration up to 2 hours after surgery

Emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale every 15 minutes

次要结局

  • Pain(From end of gas administration up to 2 hours after surgery)
  • Heart rate(From start of induction until end of surgery)
  • Bispectral Index(From start of induction until end of surgery)
  • Blood pressure(From start of induction until end of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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