pEEG-Guided Anesthesia and Behavioral Outcomes in Children

NCT07473024 | Recruiting

• 1 other identifier: 2026/36
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Behavior Change; Behavior Child Problems; Anesthesia Depth Monitoring

Outcome Measures

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.

  12-24 months after surgery

Secondary Outcomes (3)

• Incidence of negative postoperative behavioral changes (PONB)

  12-24 months after surgery

• PHBQ subscale scores

  12-24 months after surgery

• Change in PHBQ score between early postoperative period and long-term follow-up

  1 month and 12-24 months after surgery

Study Arms (2)

EEG-Guided Anesthesia

EXPERIMENTAL

Children in this group received intraoperative anesthesia management guided by processed electroencephalography (pEEG). Anesthetic depth was titrated using EEG-derived parameters including Patient State Index (PSI) and Spectral Edge Frequency 95 (SEF95) to maintain an appropriate level of anesthesia during surgery.

Device: Processed EEG Monitoring

Standard Anesthesia Management

ACTIVE COMPARATOR

Children in this group received standard anesthesia management without the use of processed electroencephalography monitoring. Anesthetic depth was managed according to conventional clinical parameters and routine monitoring.

Other: Standard Anesthesia Management

Interventions

Processed EEG Monitoring DEVICE

Processed electroencephalography monitoring was used intraoperatively to guide anesthetic depth using Patient State Index (PSI)

EEG-Guided Anesthesia

Standard Anesthesia Management OTHER

Standard intraoperative anesthesia management without the use of processed EEG monitoring.

Standard Anesthesia Management

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Istanbul, 340093, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Ricci Z, Robino C, Rufini P, Cumbo S, Cavallini S, Gobbi L, Brocchi A, Serio P, Romagnoli S. Monitoring anesthesia depth with patient state index during pediatric surgery. Paediatr Anaesth. 2023 Oct;33(10):855-861. doi: 10.1111/pan.14711. Epub 2023 Jun 19.

  PMID: 37334678 BACKGROUND

• Stargatt R, Davidson AJ, Huang GH, Czarnecki C, Gibson MA, Stewart SA, Jamsen K. A cohort study of the incidence and risk factors for negative behavior changes in children after general anesthesia. Paediatr Anaesth. 2006 Aug;16(8):846-59. doi: 10.1111/j.1460-9592.2006.01869.x.

  PMID: 16884468 BACKGROUND

• Faulk DJ, Twite MD, Zuk J, Pan Z, Wallen B, Friesen RH. Hypnotic depth and the incidence of emergence agitation and negative postoperative behavioral changes. Paediatr Anaesth. 2010 Jan;20(1):72-81. doi: 10.1111/j.1460-9592.2009.03191.x. Epub 2009 Nov 23.

  PMID: 19968807 BACKGROUND

• Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• Uhl K, Cravero JP. Measuring behavioral and emotional changes in children following hospitalization: Limitations and future directions. Paediatr Anaesth. 2019 Nov;29(11):1083-1085. doi: 10.1111/pan.13746. Epub 2019 Oct 8.

  PMID: 31541499 BACKGROUND

• Karling M, Hagglof B. Child behaviour after anaesthesia: association of socioeconomic factors and child behaviour checklist to the Post-Hospital Behaviour Questionnaire. Acta Paediatr. 2007 Mar;96(3):418-23. doi: 10.1111/j.1651-2227.2007.00108.x.

  PMID: 17407469 BACKGROUND

• Jenkins BN, Kain ZN, Kaplan SH, Stevenson RS, Mayes LC, Guadarrama J, Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Paediatr Anaesth. 2015 Jul;25(7):738-45. doi: 10.1111/pan.12678. Epub 2015 May 9.

  PMID: 25958978 BACKGROUND

• Vernon DT, Schulman JL, Foley JM. Changes in children's behavior after hospitalization. Some dimensions of response and their correlates. Am J Dis Child. 1966 Jun;111(6):581-93. doi: 10.1001/archpedi.1966.02090090053003. No abstract available.

  PMID: 5939538 BACKGROUND

Central Study Contacts

Meltem Savran Karadeniz Professor

CONTACT

009005334845563; mskaradeniz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Although EEG electrodes were applied in all participants, processed EEG values were not visible to the anesthesia team in the standard anesthesia group, and anesthetic management was performed according to conventional clinical parameters.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants included in this study were previously enrolled in a randomized clinical study comparing EEG-guided anesthesia with standard anesthesia management without processed EEG monitoring. In the present follow-up study, no new intervention is applied. Children from both groups will be contacted 12-24 months after surgery, and long-term postoperative behavioral outcomes will be evaluated using the Post-Hospitalization Behavior Questionnaire (PHBQ). Behavioral outcomes will be compared between children who previously received EEG-guided anesthesia and those who received standard anesthesia management.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): August 22, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

TU (1)