Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
研究概览
简要总结
The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)
详细描述
The process of surgery and anaesthesia can be an extremely frightening and stressful event for a child, and is frequently followed by negative postoperative behavioural changes. This Event could be associated with poor postoperative outcome and long term behavior problems like anxiety, eating or sleeping disorders. The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA). After anesthesia initiation, anesthesia maintenance should be done with sevoflurane or Tiva. The effect of behavioral changes in children in the context of anesthesia techniques should be evaluate by post hospitalisation behavior and Strengths and Difficulties Questionnaire at first, second and fourth week. Early postoperative problems like postoperative nausea and vomiting, pain level, pain therapy and postoperative awareness should be evaluate too.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elective Operation
- •operation in general anesthesia in combination with regional anesthesia
- •Age 2-10 years
- •ASA classification 1 or 2 (without severe basic disease or disability)
排除标准
- •Lack of Consensus
- •general anesthesia during the last 3 months before or 4 weeks after the procedure
- •PONV prophylaxis with droperidol
- •severe known growth factor
- •mental pre-existing conditions and behavioral abnormalities
- •contraindications for one of the used study medications
- •insufficient regional anesthesia
- •secondary intervention within of the 4-week follow-up
结局指标
主要结局
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
时间窗: fourth week postoperative
child's PHBQ score fourth week postoperatively
SDQ Questionnaire score postoperatively
时间窗: fourth week postoperative
child's SDQ score fourth week postoperatively
次要结局
- postoperative pain Level (by CHEOPS)(in the first postoperative week (3 times a day))
- Intraoperative awareness(in the first and second postoperative day)
- postoperative pain Level (by VAS)(in the first postoperative week (3 times a day))
- postoperative pain medication(in the first postoperative week)
- postoperative Nausea and vomiting(in the first and second postoperative day)