Monitoring anesthesia depth with patient state index during pediatric surgery.
Zaccaria Ricci, Chiara Robino, Paolo Rufini...
https://pubmed.ncbi.nlm.nih.gov/37334678Actively Recruiting
Phase Not Applicable
Age: 3Years - 10Years
All Genders
ID07473024
Long-Term Behavioral Outcomes After pEEG-Guided Anesthesia in Children Using the Post-Hospitalization Behavior Questionnaire
Led by Istanbul University · Updated on 2026-03-17
230
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how processed electroencephalography (pEEG) monitoring during surgery affects long-term behavioral changes in children aged 3 to 10 years. Behavioral changes after surgery and anesthesia, such as anxiety and sleep problems, can last for different periods and may impact children's well-being and family life. While early postoperative behavior has been studied, this research focuses on outcomes 12 to 24 months after surgery using a validated questionnaire called the Post-Hospitalization Behavior Questionnaire (PHBQ). Children who had surgery lasting more than one hour were randomly assigned to two groups: one receiving anesthesia guided by pEEG monitoring to adjust anesthetic depth with parameters like Patient State Index (PSI) and Spectral Edge Frequency 95 (SEF95), and the other receiving standard anesthesia management without pEEG. The initial study assessed behavior within the first month after surgery; now, this follow-up study reassesses behavior 12 to 24 months later to compare long-term effects between the two groups. During the study, parents or guardians will be contacted for a telephone interview to complete the PHBQ, which evaluates various behavioral domains such as anxiety, eating, aggression, and sleep. Researchers will compare PHBQ scores from the early postoperative period and long-term follow-up to understand if EEG-guided anesthesia influences recovery and behavior over time. The study also monitors for negative postoperative behavioral changes and examines behavioral score changes between time points.
CONDITIONS
Brief Title
pEEG-Guided Anesthesia and Behavioral Outcomes in Children
Who Can Participate
Age: 3Years - 10Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 10 years
- Surgery duration longer than 1 hour
- Undergoing urology, plastic surgery, or pediatric surgery procedures
- Availability of early postoperative PHBQ data
- Verbal consent from parents or legal guardians for follow-up telephone interview
You will not qualify if you...
- Neuromotor developmental abnormalities
- History of epilepsy or use of antiepileptic medication
- Need for postoperative intensive care unit admission
- Emergency surgical procedures
- Inability to contact family or refusal of verbal consent for telephone interview
- Undergoing another surgical procedure between initial surgery and follow-up period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Duration of surgery
Participants undergo surgery lasting longer than one hour under general anesthesia with either EEG-guided anesthesia management using processed electroencephalography (pEEG) or standard anesthesia management without pEEG monitoring.
1 visit (in-person on surgery day)
Post-operative Follow-up
Duration - Up to 1 month after surgery
Participants are evaluated for early postoperative behavioral changes using the Post-Hospitalization Behavior Questionnaire (PHBQ) within the first postoperative month.
1 follow-up visit (in-person or telephone)
Long-term Monitoring
Duration - 12 to 24 months after surgery
Participants are contacted 12 to 24 months after surgery to reassess long-term behavioral outcomes using the PHBQ via telephone interview.
1 follow-up visit (telephone interview)
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
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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Published Research Related To This Trial
A cohort study of the incidence and risk factors for negative behavior changes in children after general anesthesia.
Robyn Stargatt, Andrew J Davidson, Grace H Huang...
https://pubmed.ncbi.nlm.nih.gov/16884468Hypnotic depth and the incidence of emergence agitation and negative postoperative behavioral changes.
Debra J Faulk, Mark D Twite, Jeannie Zuk...
https://pubmed.ncbi.nlm.nih.gov/19968807Preoperative anxiety in children. Predictors and outcomes.
Z N Kain, L C Mayes, T Z O'Connor...
https://pubmed.ncbi.nlm.nih.gov/8953995Measuring behavioral and emotional changes in children following hospitalization: Limitations and future directions.
Kristen Uhl, Joseph P Cravero
https://pubmed.ncbi.nlm.nih.gov/31541499Child behaviour after anaesthesia: association of socioeconomic factors and child behaviour checklist to the Post-Hospital Behaviour Questionnaire.
M Karling, B Hägglöf
https://pubmed.ncbi.nlm.nih.gov/17407469Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery.
Brooke N Jenkins, Zeev N Kain, Sherrie H Kaplan...
https://pubmed.ncbi.nlm.nih.gov/25958978Changes in children's behavior after hospitalization. Some dimensions of response and their correlates.
D T Vernon, J L Schulman, J M Foley
https://pubmed.ncbi.nlm.nih.gov/5939538