Trials / Completed
CompletedNCT07141797
Impact of General Anesthesia in Childhood on Cognitive Processes
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- University Hospital, Caen · Academic / Other
- Sex
- All
- Age
- 8 Years – 10 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Executive 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. |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2025-03-01
- Completion
- 2025-11-01
- First posted
- 2025-08-26
- Last updated
- 2026-01-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07141797. Inclusion in this directory is not an endorsement.