Numerous preclinical evidence has confirmed that most commonly-used general anesthetics can affect neurodevelopment of young animals adversely, causing both structural defect of brain and cognitive impairment. However, it is unclear at present whether such effect would also occur to children exposed to general anesthesia in their early life. Several observational clinical studies and one interventional clinical trial indicated that short-time general anesthesia less than 80 minutes might be safe to cognitive development. Concerning long-time and/or multiple anesthesia exposure, some studies supported its association with long-term cognitive defects, while other studies did not. These studies are mainly retrospective or ambirectional researches. We have designed a prospective, multicenter cohort study to examine the neurodevelopment of infants exposed to anesthesia before age 2 in the first year after surgery, and compare the neurodevelopment status of infants exposed to anesthesia less than 3 hours and those more than 3 hours. The Gesell Developmental Inventory (GDI) and several neuropsychological testing batteries will be used. The anticipated outcome of the study will add reliable evidence from Asians to elucidate the relationship of anesthesia and long-term neurodevelopment of infants.
Study Type
OBSERVATIONAL
Enrollment
1,000
General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGChange of the developmental quotient of the Gesell Developmental Inventory
The Gesell Developmental Inventory has been translated into Chinese and standardized by the Beijing Children's Health Care Institute and the performance results are expressed as a developmental quotient (DQ).
Time frame: From baseline before anesthesia to 1 year after anesthesia
Change of the standardized score of the five domains of the Gesell Developmental Inventory
The five behavioral domains are gross motor, fine motor, language, adaptive, and personal-social behaviors.
Time frame: From baseline before anesthesia to 1 year after anesthesia
Change of the standardized score of the Social Maturity Scale
The Social Maturity Scale includes six domains and 132 questions designed to be completed by the parents.
Time frame: From baseline before anesthesia to 1 year after anesthesia
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