Comparison of Desflurane With Sevoflurane for School-age Children in Postoperative Cognitive Function
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- The incidence of postoperative cognitive dysfunction
研究概览
简要总结
This study compares desflurane with sevoflurane for school-age children in postoperative cognitive function.
详细描述
The postoperative cognitive dysfunction (POCD) of school-age children (6-14 age) after operation draw more attention from both society and family. It is well known that, compare with sevoflurane, desflurane could improve cognitive function in elderly patients. But whether Desflurane could improve postoperative cognitive function compare with Sevoflurane for the school-age children, there is no consistent conclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-14 age, elective no-cardiac and non-neurological surgery , ASA physical statusⅠorⅡ, no preoperative cognitive function impairment, cooperate to complete the entire test.
排除标准
- •Allergic to halogens inhaled anesthetics, malignant hyperthermia susceptible patients, intracranial hypertension, emotional disorder, hyperactivity, history of operation, mental retardation, audio-visual obstacles, history of congenital heart disease, Important organ dysfunction, history of drug abuse
- •History of epilepsy
- •Preoperative respiratory infection significantly.
研究组 & 干预措施
Group Desflurane
Anesthesia maintenance: After endotracheal intubation, patients will be randomized into Desflurane for maintenance. The gas flow rate of Desflurane group is 2 L/min, include 50％ O2 and 4～5％ Desflurane.
干预措施: Desflurane (Drug)
Group Sevoflurane
Anesthesia maintenance: After endotracheal intubation, patients will be randomized into sevoflurane for maintenance. The gas flow rate of Sevoflurane group is 2L/ min, include 50％O2 and 1.7-2.0% Sevoflurane.
干预措施: sevoflurane (Drug)
结局指标
主要结局
The incidence of postoperative cognitive dysfunction
时间窗: Within 7 days after operation
Cognitive function score should be carried out for all children at preoperative 1d, postoperative 2 d, 3d and 7d. If postoperative score compared with preoperative score drop 1 points or more, then postoperative cognitive dysfunction will be recorded.
次要结局
- age(1 day before operation)
- male(1 day before operation)
- height(1 day before operation)
- weight(preoperation)
- previous operation history(preoperation)
- the duration of anesthesia(From the time began to give the anesthetic to the time of pull out the endotracheal intubation)
- the duration of operation(Surgery end time minus the start time)
- total blood loss(The total blood loss of the whole surgery time.)
- total volume of infusion(The total volume of infusion of the whole surgery time.)
- whether there is respiratory depression in postanesthesia care unit(The period which the patient stay at post anesthesia care unit,from the time enter to postanesthesia care unit to the time leave postanesthesia care unit,the estimated period is up to 30 minutes.)
- the length of hospital stay(the time from admission to hospital to discharge from hospital,the estimated period is up to 5 days.)
- S100β(1 day after surgery)
- NSE(1 day after surgery)
研究者
Yingjie Du
Anesthesiology residency
Shengjing Hospital