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Impact of General Anesthesia in Childhood on Cognitive Processes

Impact of General Anesthesia in Childhood on Cognitive Processes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07141797
Enrollment
80
Registered
2025-08-26
Start date
2025-03-01
Completion date
2025-11-01
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Behavior Disorders, Neurodevelopmental Disorders

Keywords

general anesthesia, children, developing brain, executive functions, cognitive assessment

Brief summary

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.

Detailed description

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.

Interventions

OTHERExecutive functions assessment

Inhibition: Emotional (hot) and logical (cold) inhibition using Emotional and Classic Stroop tests. Participants identify the color of words or emotion in photos while inhibiting automatic responses. Inhibition scores are based on the difference in response times between congruent and interference conditions. Working Memory: Participants recall a sequence of points on a grid, first in the original order, then in reverse. The working memory score is the difference between the two tasks. Cognitive Flexibility: A task requiring alternation between identifying numbers as greater/less than 5 or even/odd based on color cues. Flexibility is scored by comparing response times for alternating and non-alternating tasks. Visuospatial abilities are assessed with a global-local task. Raven's Progressive Matrices will assess general intelligence, and socio-economic data will be collected.

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Inhibition/ working memory/ flexibilityDay 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).

Secondary

MeasureTime frameDescription
Visuo-spatial abilities/ measure of general intelligenceDay 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.Visuo-spatial abilities will be assessed using a global-local task, where participants identify shapes (square or circle) at either the global or local level, based on hierarchical stimuli. This evaluates attentional processing of visual details vs. overall structure. A general intelligence test will also be administered to ensure group equivalence.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026