NCT07473024 pEEG-Guided Anesthesia and Behavioral Outcomes in Children
| NCT ID | NCT07473024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2026-06-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2026-02-02 with a primary completion date of 2026-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07473024 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 10 Years, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07473024 currently recruiting?
Yes, NCT07473024 is actively recruiting participants. Contact the research team at mskaradeniz@gmail.com for enrollment information.
Where is the NCT07473024 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07473024 clinical trial?
NCT07473024 is sponsored by Istanbul University. The trial plans to enroll 230 participants.