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Recruiting NCT07473024

pEEG-Guided Anesthesia and Behavioral Outcomes in Children

Trial Parameters

Condition Anesthesia
Sponsor Istanbul University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 230
Sex ALL
Min Age 3 Years
Max Age 10 Years
Start Date 2026-02-02
Completion 2026-06-22
Interventions
Processed EEG MonitoringStandard Anesthesia Management

Brief Summary

Post-hospitalization behavioral changes are common in children after surgery and general anesthesia and may persist for varying durations depending on individual and perioperative factors. The Post-Hospitalization Behavior Questionnaire (PHBQ) is a well-validated instrument widely used to evaluate negative postoperative behavioral changes in pediatric patients following hospitalization or surgical procedures. Although early postoperative behavioral disturbances have been extensively studied, most research has focused on short-term outcomes within the first weeks after surgery, while long-term behavioral outcomes remain insufficiently investigated. Processed electroencephalography (pEEG) monitoring provides an objective method for assessing anesthetic depth during surgery. Parameters such as the Patient State Index (PSI) and Spectral Edge Frequency 95 (SEF95) allow dynamic evaluation of cortical activity and may help optimize anesthetic administration by preventing excessively deep or inadequate anesthesia. Improved anesthetic depth management may theoretically influence postoperative recovery and behavioral outcomes. In the initial randomized study, early postoperative behavioral assessments were obtained within the first postoperative month using the Post-Hospitalization Behavior Questionnaire (PHBQ). In the present follow-up study, children will be contacted again 12-24 months after surgery to evaluate long-term behavioral outcomes. PHBQ scores at long-term follow-up will be compared between children who previously received EEG-guided anesthesia and those managed with standard anesthesia without processed EEG monitoring. By examining both early and long-term behavioral outcomes, this study aims to determine whether intraoperative EEG-guided anesthesia management influences postoperative behavioral changes in the pediatric population.

Eligibility Criteria

Inclusion Criteria: * Children aged 3-10 years * Surgical duration longer than 1 hour * Patients undergoing urology, plastic surgery, or pediatric surgery procedures * Availability of early postoperative PHBQ data * Verbal consent from parents or legal guardians for participation in the follow-up telephone interview Exclusion Criteria: * Patients with neuromotor developmental abnormalities * History of epilepsy or antiepileptic medication use * Patients requiring postoperative intensive care unit admission * Emergency surgical procedures * Inability to contact the family or refusal of verbal consent for the telephone interview * Patients who underwent another surgical procedure between the initial surgery and the follow-up period

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