Namsos Anaesthesia Children Outcome Study (NACOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 761
- 试验地点
- 2
- 主要终点
- Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10
研究概览
简要总结
Behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. Persisting behavioral changes may affect emotional and cognitive development. It is known that both type of surgery and anesthetic management affect the occurrence of behavioral disturbances. Specifically, differences in occurrence were found after sevoflurane anesthesia and propofol anesthesia, two anesthetics that are generally used in practice. However, evidence is based on methodologically weak studies.
The described occurrence of behavioral disturbances in children after anesthesia is not in line with the investigators' clinical experience, and neither are the described differences in occurrence between sevoflurane anesthesia and propofol anesthesia. This study will compare emergence delirium and behavioral changes after discharge from hospital in children who had surgery for removal of their tonsils under sevoflurane anesthesia versus propofol anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adenotomy and/or tonsillotomy and/or tonsillectomy
- •ASA physical status class I or II
排除标准
- •unexperienced ear-nose-throat (ENT) surgeon (ENT surgeon < 1 year of training, ENT surgeon without experience with the use of laryngeal mask as airway during adenotomy/tonsillotomy/tonsillectomy)
- •preoperative syndromes
- •ASA physical status class > 2
- •missing written consent from parents/guardians
研究组 & 干预措施
Propofol
Anesthesia is maintained with Propofol
干预措施: Propofol (Drug)
Sevoflurane
Anesthesia is maintained with Sevoflurane
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10
时间窗: 1 hour
A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring
次要结局
- Post Hospital Behavioral Questionnaire (PHBQ)(30 days)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4(1 hour)