pEEG-Guided Anesthesia and Behavioral Outcomes in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-10
SponsorIstanbul University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with neuromotor developmental abnormalities
History of epilepsy or antiepileptic medication use
Patients requiring postoperative intensive care unit admission
Emergency surgical procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Processed EEG Monitoring
DeviceProcessed electroencephalography monitoring was used intraoperatively to guide anesthetic depth using Patient State Index (PSI)
Standard Anesthesia Management
Other interventionStandard intraoperative anesthesia management without the use of processed EEG monitoring.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: EEG-Guided AnesthesiaExperimental treatment 1 intervention
Group B: Standard Anesthesia ManagementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-Hospitalization Behavior Questionnaire (PHBQ) score
Long-term postoperative behavioral changes will be assessed using the Post-Hospitalization Behavior Questionnaire (PHBQ). The PHBQ is a 27-item validated scale evaluating behavioral changes compared with the child's pre-hospitalization status. Higher scores indicate greater behavioral change.
Time frame
12-24 months after surgerySecondary outcomes
1
Incidence of negative postoperative behavioral changes (PONB)
Presence of negative behavioral changes defined according to deterioration in PHBQ items.
Time frame
12-24 months after surgery2
PHBQ subscale scores
Evaluation of behavioral changes using the Post Hospitalization Behavior Questionnaire (PHBQ). The PHBQ consists of multiple domains including separation anxiety, sleep-related anxiety, eating disturbances, aggression toward authority, apathy/withdrawal, and general anxiety/regression. The total PHBQ score ranges from 27 to 135, with higher scores indicating more negative postoperative behavioral changes.
Time frame
12-24 months after surgery3
Change in PHBQ score between early postoperative period and long-term follow-up
Change in behavioral outcomes assessed with the Post Hospitalization Behavior Questionnaire (PHBQ) between the early postoperative period and long-term follow-up. The PHBQ total score ranges from 27 to 135, with higher scores indicating more negative postoperative behavioral changes. Comparison of PHBQ scores obtained: within the first postoperative month and at long-term follow-up.
Time frame
1 month and 12-24 months after surgerySponsors and contacts
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Source ClinicalTrials.gov