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Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

Effect of Preoperative Inflammatory Biomarkers on Postoperative Delirium in Children Undergoing Circumcision

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07323485
Enrollment
140
Registered
2026-01-07
Start date
2026-01-18
Completion date
2026-07-25
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Biomarkers, Pediatric Anesthesia, Postoperative Delirium

Keywords

Circumcision, Pediatric Anesthesia, Inflammatory Biomarkers, Postoperative Delirium

Brief summary

Postoperative delirium may occur in children after general anesthesia, even following short procedures such as circumcision. Preoperative systemic inflammation has been associated with postoperative delirium in adults, but data in pediatric patients are limited. This prospective observational study aims to evaluate the association between preoperative inflammatory biomarkers and postoperative delirium in children aged 2-12 years undergoing elective circumcision under general anesthesia. Inflammatory biomarkers derived from routine complete blood count parameters, including NLR, PLR, MLR, SII, and SIRI, will be analyzed. Postoperative delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale in the post-anesthesia care unit. The relationship between inflammatory biomarkers and delirium development and severity will be evaluated. This study seeks to identify simple preoperative markers that may help predict postoperative delirium risk in pediatric patients.

Interventions

Blood samples will be collected preoperatively to assess inflammatory biomarkers, including the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), monocyte-to-lymphocyte ratio (MLR), and the systemic inflammation response index (SIRI). These parameters will be analyzed in relation to the incidence of emergence delirium within the first 2 hours following pediatric circumcision. No experimental drug or medical device will be used as part of the study; all procedures will be performed within the scope of standard perioperative care.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
2 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative DeliriumWithin 2 hours postoperativelyPostoperative delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED Scale consists of 5 items, each scored from 0 to 4, yielding a total score ranging from 0 to 20. Higher scores indicate more severe emergence delirium, representing a worse clinical outcome. A PAED score ≥10 will be considered indicative of clinically significant postoperative delirium.

Secondary

MeasureTime frameDescription
Correlation between preoperative inflammatory biomarkers (NLR, PLR, SII, SIRI, MLR) and delirium severity (total PAED score).Within 2 hours postoperativelyThe correlation between preoperative inflammatory biomarkers (NLR, PLR, SII, SIRI, and MLR) and the severity of postoperative delirium, as measured by the total Pediatric Anesthesia Emergence Delirium (PAED) score, will be evaluated. The PAED Scale consists of 5 items, each scored from 0 to 4, yielding a total score ranging from 0 to 20. Higher scores indicate more severe emergence delirium, representing a worse clinical outcome. A PAED score ≥10 will be considered indicative of clinically significant postoperative delirium.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026