Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5
研究概览
简要总结
In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 2 years of age who underwent general anesthesia for elective surgeries inlcuding urology, surgery, plastic surgery, orthopedics, and otolaryngology, etc, which were non-staged and non-repetitive procedures
- •American Society of Anesthesiology Physical Status I, II
排除标准
- •Allergies to narcotic analgesics
- •With massive bleeding or shock
- •Heart, lung, kidney or liver disease
- •Central / peripheral nervous system disease and disorder
- •Any physical deformity and disorder, genetic disease, chromosomal disease
- •Previous history of general anesthesia or sedation
- •Developmental delay identified through K-DST results
- •Additional exposure to general anesthetics or sedative drugs during follow-up
研究组 & 干预措施
Control group
General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
干预措施: Sevoflurane (Drug)
Dexmedetomidine-remifentanil(DEX-R) group
General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg loading, and 1 mcg/kg/hr continuous infusion) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
干预措施: dexmedetomidine (Drug)
Dexmedetomidine-remifentanil(DEX-R) group
General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg loading, and 1 mcg/kg/hr continuous infusion) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
干预措施: remifentanil (Drug)
Dexmedetomidine-remifentanil(DEX-R) group
General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg loading, and 1 mcg/kg/hr continuous infusion) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5
时间窗: When the patient's age is 5 years after surgery
categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline
次要结局
- Leiter International Performance Scale at age of 30 months(When the patient's age is 30 months old after surgery)
- Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7(When the patient's age is 7 years old after surgery)
- Child Behavior Checklist results(When the patient's age become 30 months, 5 years and 7 years old after surgery)
研究者
Ji-Hyun Lee
Clinical Professor
Seoul National University Hospital