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Completed

NCT Number: NCT07141797

Impact of General Anesthesia in Childhood on Cognitive Processes

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.

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Caen Normandie

Caen, Normandy, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Executive functions assessment

Other

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.

Primary outcomes

  1. Inhibition/ working memory/ flexibility

    Time frame: 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).

Secondary outcomes

  1. Visuo-spatial abilities/ measure of general intelligence

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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