Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- change of Baseline Gesell Developmental Scale after 6 month
研究概览
简要总结
The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after unilateral or bilateral cochlear implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital
- •Patients who have not participated in other clinical trials
- •ASA class I-II selective operation without any acute infectious diseases or systematic diseases
- •Infant's family members agree to participated in the trials and sign the informed consent
排除标准
- •Reject to sign the informed consent and participate in the trials
- •Patients with severe liver and kidney damage or other heart, lung and nervous system diseases
- •The Gesell developmental scale is less than 86 in motor behavior and physical energy
- •With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice
- •Infant who is allergic to egg and milk
- •Family history of malignant hyperthermia
- •Allergy to anesthetic drugs
结局指标
主要结局
change of Baseline Gesell Developmental Scale after 6 month
时间窗: change in 6 months after surgery
Neurobehavior effects
次要结局
- change of Baseline Gesell Developmental Scale after 12 month(change in 12 months after surgery)
研究者
Jingjie Li
associate chief physician
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University