- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473024
pEEG-Guided Anesthesia and Behavioral Outcomes in Children
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meltem Savran Karadeniz Professor
- Phone Number: 009005334845563
- Email: mskaradeniz@gmail.com
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 340093
- Recruiting
- Istanbul University
-
Contact:
- Istanbul University Istanbul Faculty of Medicine
- Phone Number: 009005334845563
- Email: mskaradeniz@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EEG-Guided Anesthesia
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.
|
Processed electroencephalography monitoring was used intraoperatively to guide anesthetic depth using Patient State Index (PSI)
|
|
Active Comparator: Standard Anesthesia Management
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.
|
Standard intraoperative anesthesia management without the use of processed EEG monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Hospitalization Behavior Questionnaire (PHBQ) score
Time Frame: 12-24 months after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of negative postoperative behavioral changes (PONB)
Time Frame: 12-24 months after surgery
|
Presence of negative behavioral changes defined according to deterioration in PHBQ items.
|
12-24 months after surgery
|
|
PHBQ subscale scores
Time Frame: 12-24 months after surgery
|
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. |
12-24 months after surgery
|
|
Change in PHBQ score between early postoperative period and long-term follow-up
Time Frame: 1 month and 12-24 months after surgery
|
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. |
1 month and 12-24 months after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026/36
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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