Hypnotic 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/19968807/Actively Recruiting
Led by Istanbul University · Updated on 2026-03-17
230
Participants Needed
1
Research Sites
8 weeks
Total Duration
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 childrens 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
pEEG-Guided Anesthesia and Behavioral Outcomes in Children
M
Meltem Savran Karadeniz Professor
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Istanbul University
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
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)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Lead Sponsor