Inflammation markers and postoperative delirium after pediatric circumcision
Effect of Preoperative Inflammatory Biomarkers on Postoperative Delirium in Children Undergoing Circumcision
This project will test whether common blood inflammation markers taken before surgery can help predict which children aged 2 to 12 develop delirium right after circumcision under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | Male |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Altındağ, Ankara) |
| Trial ID | NCT07323485 on ClinicalTrials.gov |
What this trial studies
This prospective observational study will enroll children aged 2–12 undergoing elective circumcision under general anesthesia. Preoperative inflammatory biomarkers derived from routine complete blood count parameters (NLR, PLR, MLR, SII, SIRI) will be measured. Postoperative emergence delirium will be recorded in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium (PAED) scale, and associations between biomarker levels and delirium occurrence and severity will be analyzed. Children with neurological or psychiatric diagnoses, hematologic/hormonal disorders, ASA III–IV status, or incomplete preoperative labs will be excluded.
Who should consider this trial
Good fit: Ideal candidates are children aged 2–12 scheduled for elective circumcision under general anesthesia with ASA physical status I–II whose parents provide consent and who can give age-appropriate assent.
Not a fit: Children outside the 2–12 age range, those with neurological/psychiatric or hematologic disorders, ASA III–IV patients, emergency procedures, or those lacking preoperative laboratory data are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, simple preoperative blood-count markers could help identify children at higher risk for emergence delirium so clinicians can plan closer monitoring or preventive steps.
How similar studies have performed: Adult studies have reported links between preoperative inflammatory markers and postoperative delirium, but comparable pediatric evidence is limited and the approach is relatively untested in children.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 2-12 years. * Patients scheduled to undergo elective circumcision under general anesthesia. * Patients classified as ASA physical status I-II. * Patients whose parents or legal guardians provide written informed consent, and whose age-appropriate verbal assent is obtained from the child. * Patients in whom anesthesia and surgical procedures are performed according to standard institutional protocols throughout the study period. Exclusion Criteria: * Children with a history of neurological or psychiatric disorders (e.g., epilepsy, developmental delay, autism spectrum disorder, anxiety disorders). * Patients classified as ASA physical status III-IV. * Patients with incomplete preoperative laboratory data or with hematological or hormonal disorders that may affect inflammatory parameters. * Patients who develop excessive sedation after premedication or whose preoperative assessment cannot be completed. * Patients with protocol deviations during surgery or anesthesia (e.g., additional medications, prolonged surgical duration, or changes in procedure due to complications). * Patients whose parents or legal guardians do not provide consent or who decline participation.
Where this trial is running
Altındağ, Ankara
- Ankara Etlik City Hospital — Altındağ, Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ahmet Murat Gül
- Email: dr_gag@hotmail.com
- Phone: 00905071399560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.