Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium
研究概览
简要总结
Emergence delirium is a significant problem, particularly in children. However the incidence, preventative strategies, and management of emergence delirium remain unclear. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of emergence delirium in children under 16 years scheduled for elective surgery using electroencephalogram. The "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" (Sikich et al. 2004) is used to screen for the occurrence of emergence delirium in the post anesthesia care unit.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female children aged under 16 years
- •planned elective surgery
- •informed consent by parents or legal guardians
排除标准
- •history of neurological or psychiatric disease
- •delayed development
- •inability of the parents or legal guardians to speak or read Chinese
- •participation in another prospective interventional clinical study during this study
结局指标
主要结局
Incidence of emergence delirium
时间窗: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. A peak PAED value ≥ 10 is considered emergence delirium.
次要结局
- Type of surgery(During the operation)
- Relative power of each brain waves(from stay at the preoperative holding room to discharge of the child from the Post-Anesthesia Care Unit, , an average of 3 hours)
- Compliance of the children during induction(Procedure (At the beginning of the Induction))
- Body temperature(During the operation, an average of 1 hour)
- Duration of anesthesia(During the anesthesia, an average of 1 hour)
- Blood pressure(During the operation, an average of 1 hour)
- Heart rate(During the operation, an average of 1 hour)
- Duration of surgery(During the operation, an average of 1 hour)
- Number of Participants with postoperative organ complications(Participants will be followed for the duration of hospital stay, an average of 5 days.)
- Hospital length of stay(Participants will be followed for the duration of hospital stay, an average of 5 days.)
- Preoperative anxiety of children(baseline (At the preoperative holding room))
- Number of Participants with adverse events(Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, , an average of 1 hour)
- Postoperative pain: FLACC- Scale(Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour)
- Severity of emergence Delirium(Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour)
- Duration of emergence Delirium(Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour)
- The level of consciousness(Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour)
- Post-Anesthesia Care Unit (PACU) stay time(During the stay in the Post-Anesthesia Care Unit, an average of 1 hour)
- Incidence of behavioral problem(Up to 30 postoperative days)
研究者
Hua Zheng
Principal Investigator
Huazhong University of Science and Technology