Impact of General Anesthesia in Childhood on Cognitive Processes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Inhibition/ working memory/ flexibility
研究概览
简要总结
This study aims to evaluate the potential long-term cognitive effects of general anesthesia administered before the age of 4. Specifically, it investigates executive functions-including inhibition, working memory, and cognitive flexibility-in children aged 9 to 10 years. A secondary objective assesses visuo-spatial attention.
Participants will be divided into two groups: (1) children exposed to a single general anesthesia for functional surgery before age 4, and (2) a control group with no such exposure. Cognitive performance will be assessed through computerized tasks with time constraints, conducted in a school setting. The study is designed to compare these groups prospectively in order to determine whether early exposure to general anesthesia is associated with differences in cognitive functioning at school age.
详细描述
This study investigates the long-term cognitive effects of early exposure to general anesthesia in children. Specifically, it focuses on evaluating executive functions-namely inhibition, working memory, and cognitive flexibility-in children aged 9-10 years who underwent functional surgery with general anesthesia before age 4. A secondary objective includes assessing visuo-spatial attention and general intelligence.
Executive functions will be measured using standardized, computerized tasks. Inhibition will be assessed through both an emotional Stroop (hot inhibition) and a classic Stroop task (cold inhibition). Working memory will be evaluated using a spatial sequence recall task on a grid, in both forward and reverse order. Flexibility will be measured through an adapted version of the computerized Trail Making Test, requiring rule-switching between tasks based on stimulus color.
Visuo-spatial abilities will be assessed using a global-local task involving hierarchical visual stimuli, allowing for evaluation of attention to detail versus overall structure. General intelligence will be measured using Raven's Progressive Matrices.
Participants will be recruited from selected elementary schools in partnership with local educational authorities. Eligible children will be grouped based on prior exposure to general anesthesia, matched on age, sex, and socio-economic status. Testing will occur in school settings during class time under controlled, blinded conditions. Data will be anonymized and processed in accordance with GDPR standards. Statistical analyses will include MANOVA and linear models to assess group differences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 9-10 years Mainstream class (non-specialized) Requirement for information on the right to object Requirement for affiliation with social security French-speaking
排除标准
- •Criteria for "Parents" Parental refusal Twins Exposure to general anesthesia during pregnancy, including cesarean section under general anesthesia
- •Pregnancy-related pathology:
- •Pregnancy-induced hypertension
- •Preeclampsia
- •Gestational diabetes
- •Threat of preterm labor
- •Depressive syndrome
- •Chronic treatment during pregnancy:
- •Pregnancy-induced hypertension: antihypertensive treatment (beta-blockers, calcium channel blockers)
- •Preeclampsia: antihypertensive treatment (beta-blockers, calcium channel blockers), magnesium sulfate
- •Gestational diabetes: dietary regimen, insulin
- •Threat of preterm labor: prenatal corticosteroid therapy, magnesium sulfate
- •Depressive syndrome: antidepressant psychotropic treatment Smoking during pregnancy, alcohol consumption during pregnancy, drug use during pregnancy Criteria for "Children" Child refusal to participate in the study Premature birth (i.e., before 37 weeks of gestation) Evolving or chronic psychiatric pathology, whether or not requiring chronic treatment Evolving or chronic neurological or neuromuscular pathology Genetic pathology Any chronic pathology requiring specialized follow-up and/or treatment (doctor, psychologist, speech therapist) Specialized neuro-pediatric or pediatric psychiatric follow-up, or follow-up with a psychologist or speech therapist during childhood Neuro-visual disorders (excluding normal vision with correction) Hearing disorders, whether or not using hearing aids Chronic otorhinolaryngological pathology, including sleep apnea syndrome, with or without apparatus Developmental disorders: ADHD, autism, or other, whether or not requiring chronic treatment Pediatric intensive care hospitalization Conventional hospitalization for more than 1 week during childhood Child who underwent multiple general anesthesias before the age of 4
研究组 & 干预措施
General anesthesia group
Children aged 9 or 10 at the time of the study, who were exposed to a single general anesthesia for a functional surgery during childhood before the age of 4.
干预措施: Executive functions assessment (Other)
Control group
Children aged 9 or 10 at the time of the study, who were not exposed to general anesthesia for surgery during childhood.
干预措施: Executive functions assessment (Other)
结局指标
主要结局
Inhibition/ working memory/ flexibility
时间窗: Day 1 (single school testing session). The assessment of all judgment criteria is conducted during a 30-minute timed testing session on a computer, with the child present.
Cold Inhibition: Measured by the Stroop task (color-word interference). Unit: reaction time difference (ms). Hot Inhibition: Measured by the emotional Stroop (faces and emotional words). Unit: reaction time difference (ms). Working Memory: Assessed via forward and backward spatial recall on a grid. Unit: number of correct sequences. Cognitive Flexibility: Measured by a rule-switching task (digit color cues: magnitude vs. parity). Flexibility is the RT difference between switch and control tasks. Unit: reaction time difference (ms).
次要结局
- Visuo-spatial abilities/ measure of general intelligence(Day 1 (single school testing session). The assessment of all judgment criteria is conducted during a 30-minute timed testing session on a computer, with the child present.)