Actively Recruiting

Phase Not Applicable
Age: 3Years - 10Years
All Genders
NCT07473024

pEEG-Guided Anesthesia and Behavioral Outcomes in Children

Led by Istanbul University · Updated on 2026-03-17

230

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

pEEG-Guided Anesthesia and Behavioral Outcomes in Children

Who Can Participate

Age: 3Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 10 years
  • Surgical procedure lasting longer than 1 hour
  • Undergoing urology, plastic surgery, or pediatric surgery
  • Availability of early postoperative PHBQ data
  • Verbal consent from parents or guardians for telephone follow-up interview
Not Eligible

You will not qualify if you...

  • Neuromotor developmental abnormalities
  • History of epilepsy or use of antiepileptic medication
  • Requirement for postoperative intensive care unit admission
  • Emergency surgical procedures
  • Inability to contact family or refusal of verbal consent for telephone interview
  • Having undergone another surgical procedure between initial surgery and follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istanbul University

Istanbul, Istanbul, Turkey (Türkiye), 340093

Actively Recruiting

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Research Team

M

Meltem Savran Karadeniz Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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