Psychological and Behavioral Change Before and After General Anesthesia in Preschool Children: Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change of T-score of total score of child behavior checklist 1.5-5 (CBCL 1.5-5)
研究概览
简要总结
Most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. In this process, various side effects may occur.
Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. Previous studies found that ED and postoperative behavioral problems might be connected. Preschoolers are the most vulnerable group in developing ED after general anesthesia, however, it is difficult to evaluate the psychiatric problems at this age.
The Child Behavior Checklist (CBCL) 1.5-5 is an internationally well-known standardized tool for assessment of developmental psychopathology, consisted of 99 problem items. Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.
In this study, the investigators would observe the behavioral and emotional changes of the child using the CBCL 1.5-5 between before and after the general anesthesia.
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
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2 and 7 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive surgery under general anesthesia
排除标准
- •If the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder
- •with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc
- •refusal of consent
- •Any visual or auditory problems of the primary responder of CBCL
- •recently received psychiatric medication or sleep supplements
- •Recent history (within a month) of received general anesthesia or surgery
结局指标
主要结局
Change of T-score of total score of child behavior checklist 1.5-5 (CBCL 1.5-5)
时间窗: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. The CBCL 1.5-5 included 99 questions that describe specific kinds of behavioral and emotional problems for preschool children. Questions are scored on syndrome scales designated as emotionally reactive, anxious/depressed, somatic complaints, withdrawn, attention problems, aggressive behavior, and sleep problems. Higher scores mean great behavioral disturbances.
Change of T-score of sleep problems
时间窗: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. The subjects are asked to answer the questions with a 3 point scale: 0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Change of T-score of each externalizing problems
时间窗: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. Externalizing problems are consisted of following 2 categories : Attention problems and aggressive behavior. The subjects are asked to answer the questions with a 3 point scale: 0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Change of T-score of each internalizing problems
时间窗: before anesthesia induction and 1 week after the surgery
T-score is the scale in order to indicate the relative position within the whole group that has been standardized, the average and standard deviation of the percentile distribution obtained through the origin sum of score. Internalizing problems are consisted of following 4 categories : emotionally reactive, withdrawn, somatic complaints, and anxious/depressed. The subjects are asked to answer the questions with a 3 point scale: 0 for not true of the child; 1 for somewhat or sometimes true, and 2 for very true of often true. The scores for problems were calculated according to the CBCL manuals. Higher scores mean great behavioral disturbances.
Emergence Delirium (ED)
时间窗: Approximately during 60 min after PACU admission
Whether ED is occurs during PACU stay in children. The determination of ED was made using parameters PAED \>12 and Watcha \>2.
次要结局
- PAED score during PACU stay(During 60 min after PACU admission)
- Watcha scale on initial, 10, 20, and 30 min(During 60 minutes after PACU admission)
- modified Yale preoperative anxiety score (mYPAS)(before anesthesia induction (about 30 min before the surgery))
- FLACC score on initial, 10, 20, and 30 min(During 60 minutes after PACU admission)
- Postoperative adverse event(During 60 minutes after the surgery)
研究者
Eugene Kim
Assistant professor
Daegu Catholic University Medical Center