Guiding children's anesthesia with processed EEG to reduce postoperative behavior changes
Long-Term Behavioral Outcomes After pEEG-Guided Anesthesia in Children: A Follow-Up Study Using the Post-Hospitalization Behavior Questionnaire
This tests whether using processed EEG monitoring during surgery reduces long-term postoperative behavior changes in children aged 3–10 undergoing common pediatric surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07473024 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares processed EEG (pEEG)-guided anesthesia to standard anesthesia management in children aged 3–10 undergoing urology, plastic, or pediatric surgeries lasting more than one hour at Istanbul University. Participants receive either pEEG monitoring with indices such as Patient State Index (PSI) and SEF95 to guide anesthetic dosing or standard care without processed EEG guidance. Behavioral outcomes are measured using the Post-Hospitalization Behavior Questionnaire (PHBQ) collected early postoperatively and via telephone follow-up to capture longer-term changes. Key exclusions include neuromotor developmental abnormalities, epilepsy, emergency surgery, postoperative ICU admission, or additional surgeries before follow-up.
Who should consider this trial
Good fit: Children aged 3–10 scheduled for urology, plastic, or pediatric procedures longer than one hour who do not have neuromotor developmental disorders or epilepsy, are not expected to need ICU care, and whose parents can provide verbal consent and participate in telephone follow-up are ideal candidates.
Not a fit: Children with neuromotor developmental abnormalities, a history of epilepsy, those requiring postoperative ICU admission, emergency cases, or those who undergo another surgery before the follow-up period are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, pEEG-guided anesthetic management could reduce negative postoperative behavioral changes and improve recovery and family well-being for affected children.
How similar studies have performed: Prior research shows processed EEG can objectively guide anesthetic depth and reduce episodes of excessive anesthesia, but evidence that it prevents long-term postoperative behavioral changes in children is limited and not well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul, Istanbul
- Istanbul University — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Meltem Savran Karadeniz Professor
- Email: mskaradeniz@gmail.com
- Phone: 009005334845563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.