跳至主要内容
临床试验/NCT02980549
NCT02980549已完成不适用

Determining the Incidence of Parasomnias (PS) and Emergence Delirium (ED)in the American Family Children's Hospital Patient Population

University of Wisconsin, Madison0 个研究点目标入组 100 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Prevalence of parasomnias (PS) and emergence delirium (ED) in children

研究概览

简要总结

Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is defined as a dissociated state of consciousness, occurring on awakening from general anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem in pre-school children, with estimates of the incidence ranging from 10-70% of children in this age group. These children are agitated, seemingly unaware of their surroundings, and typically do not respond to parents or caregivers. They are therefore at risk for self-inflicted traumatic injury and complications secondary to disruptions of intravenous lines, surgical incisions, or drains. Children with ED typically require more resources in the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED would allow for better allocation of resources in the post-anesthetic care unit (PACU).

The peak incidence of ED in children occurs in the same age range at which the peak incidence of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the description of ED; the American Academy of Sleep Medicine defines parasomnias as "undesirable physical events or experiences that occur during entry into sleep, within sleep or during arousals from sleep." Parasomnias can be diagnosed using a sleep questionnaire.

The purpose of this pilot study is to determine the incidence of ED and PS in our population, in order to determine the number of patients necessary to enroll in a larger study to either confirm or reject the hypothesis that ED and PS are correlated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients age 1-6 (inclusive) scheduled for elective ENT or urologic surgery
  • ASA I or II
  • Presence of a caregiver who is familiar with the child's sleep history

排除标准

  • Severe developmental delay
  • Children receiving clonidine
  • Medication for seizures
  • Children who have received ED treatment prior to a diagnosis of ED (clonidine, dexmedetomidine, or propofol)

结局指标

主要结局

Prevalence of parasomnias (PS) and emergence delirium (ED) in children

时间窗: 6 months

次要结局

  • score on Childrens Sleep Habits Questionnaire correlated with ED(6 months)

研究者

申办方类型
Other
责任方
Sponsor

相似试验