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AnesthesiaNCT07473024

pEEG-Guided Anesthesia and Behavioral Outcomes in Children

A study testing Processed EEG Monitoring and Standard Anesthesia Management in people with Anesthesia and Behavior Change, run by Istanbul University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 10 years
What is being tested?
Processed EEG Monitoring and Standard Anesthesia Management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Feb 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meltem Savran Karadeniz Professor contact

009005334845563

mskaradeniz@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul University

    Istanbul, Istanbul, 340093

    Istanbul University Istanbul Faculty of Medicine, 009005334845563, mskaradeniz@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Long-Term Behavioral Outcomes After pEEG-Guided Anesthesia in Children: A Follow-Up Study Using the Post-Hospitalization Behavior Questionnaire

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.

Read the detailed description

Postoperative behavioral disturbances are frequently observed in children following hospitalization, anesthesia, and surgical procedures. These behavioral changes may include anxiety, sleep disturbances, separation difficulties, regression, aggression, or withdrawal. In pediatric patients, such behavioral disturbances may negatively affect family dynamics, social functioning, and psychological well-being. Therefore, evaluating postoperative behavioral outcomes represents an important component of pediatric perioperative care.

The Post-Hospitalization Behavior Questionnaire (PHBQ) was first developed in 1966 by Vernon, Schulman, and Foley to assess behavioral changes in children following hospitalization. Since its introduction, PHBQ has become one of the most widely used and validated instruments for evaluating postoperative behavioral disturbances in pediatric populations. The questionnaire consists of 27 items designed to compare the child's current behavior with their behavior prior to hospitalization. These items assess behavioral changes across six domains: general anxiety and regression, separation anxiety, eating disturbances, aggression toward authority, apathy or withdrawal, and sleep-related anxiety. Each item is scored on a five-point Likert scale, resulting in a total score ranging from 27 to 135, where higher scores indicate greater behavioral change.

The definition of negative postoperative behavioral changes (PONB) varies across studies. Kain and colleagues defined PONB as the presence of a negative behavioral response in at least one PHBQ item. In contrast, other investigators have adopted more stringent definitions. Faulk and colleagues suggested that deterioration in at least seven PHBQ items should be considered clinically significant behavioral change. Similarly, Stargatt et al., in a large cohort study involving more than one thousand children, also defined clinically relevant postoperative behavioral disturbances as worsening in seven or more questionnaire items. These variations highlight the complexity of evaluating behavioral outcomes in pediatric populations and suggest that postoperative behavioral disturbances may be more prevalent than previously recognized.

Most studies evaluating postoperative behavioral changes using the PHBQ have focused primarily on early postoperative periods, typically within the first weeks or the first month after surgery. However, several studies have shown that certain behavioral changes-particularly sleep disturbances, separation anxiety, and withdrawal behaviors-may persist for several months following surgery. Despite these findings, studies examining behavioral outcomes beyond the first postoperative year remain extremely limited. Consequently, the long-term psychological impact of pediatric anesthesia and surgery remains incompletely understood.

Appropriate management of anesthetic depth during pediatric anesthesia is an important factor in optimizing perioperative outcomes. Excessively deep anesthesia may increase exposure to anesthetic agents, while inadequate anesthesia may lead to physiological stress responses or intraoperative awareness. Processed electroencephalography (pEEG) monitoring provides a real-time and objective assessment of brain activity and anesthetic depth during general anesthesia.

Among pEEG-derived parameters, the Patient State Index (PSI) is commonly used to estimate the depth of anesthesia. PSI values range from 0 to 100, with values between 25 and 50 generally considered indicative of an appropriate level of anesthesia for surgical procedures. Another parameter, Spectral Edge Frequency 95 (SEF95), represents the frequency below which 95% of the electroencephalographic power spectrum is contained and provides additional information regarding cortical activity and anesthetic effects on brain function. Previous studies have demonstrated that pEEG monitoring may contribute to improved anesthetic titration and more stable intraoperative anesthesia management.

In the initial randomized clinical study, children undergoing surgery lasting longer than one hour under general anesthesia were randomized to receive either EEG-guided anesthesia management or standard anesthesia management without processed EEG monitoring. Early postoperative behavioral assessments were obtained within the first postoperative month using the PHBQ.

The present study represents a long-term follow-up of this randomized cohort. Children from the original study population will be contacted 12-24 months after surgery, and long-term behavioral outcomes will be reassessed using the PHBQ. This design allows evaluation of both early postoperative behavioral changes and long-term behavioral outcomes. PHBQ scores obtained at long-term follow-up will be compared between children who previously received EEG-guided anesthesia and those who received standard anesthesia management.

By investigating the relationship between intraoperative anesthetic depth monitoring and both early and long-term behavioral changes, this study aims to provide new insights into the potential influence of EEG-guided anesthesia on postoperative neurobehavioral outcomes in pediatric patients.

Being tested
Processed EEG Monitoring, Standard Anesthesia Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Processed EEG MonitoringDevice

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

  • Standard Anesthesia ManagementOther

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

Study groups in NCT07473024
Study groupRoleWhat they receive
EEG-Guided AnesthesiaExperimentalChildren 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.
Receives: Device: Processed EEG Monitoring
Standard Anesthesia ManagementActive comparatorChildren 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.
Receives: Other: Standard Anesthesia Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12-24 months after surgery

Secondary outcomes (3)
  1. Incidence of negative postoperative behavioral changes (PONB)

    Presence of negative behavioral changes defined according to deterioration in PHBQ items.

    Measured: 12-24 months after surgery

  2. 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.

    Measured: 12-24 months after surgery

  3. 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.

    Measured: 1 month and 12-24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2026
  2. Study start2 Feb 2026
  3. Primary completion22 Jun 2026
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07473024
Sponsor's protocol ID
2026/36
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37334678
  • 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.

    PubMed 16884468
  • 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.

    PubMed 19968807
  • 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.

    PubMed 8953995
  • 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.

    PubMed 31541499
  • 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.

    PubMed 17407469
  • 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.

    PubMed 25958978
  • 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.

    PubMed 5939538

Questions about this trial

What is this clinical trial studying?

A study testing Processed EEG Monitoring and Standard Anesthesia Management in people with Anesthesia and Behavior Change, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meltem Savran Karadeniz Professor (009005334845563, mskaradeniz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Hospitalization Behavior Questionnaire (PHBQ) score (time frame: 12-24 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07473024, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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