Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

NCT07323485 | Recruiting

• 1 other identifier: AEŞH-EK-2025-299
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Anesthesia; Inflammatory Biomarkers; Postoperative Delirium

Keywords

Circumcision; Pediatric Anesthesia; Inflammatory Biomarkers; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  Postoperative 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.

  Within 2 hours postoperatively

Secondary Outcomes (1)

• Correlation between preoperative inflammatory biomarkers (NLR, PLR, SII, SIRI, MLR) and delirium severity (total PAED score).

  Within 2 hours postoperatively

Interventions

Measurement of Preoperative Inflammatory Biomarkers OTHER

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.

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 2-12 years with ASA physical status I-II undergoing elective circumcision under general anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ahmet Murat Gül

CONTACT

00905071399560; dr_gag@hotmail.com

Aslı Dönmez

CONTACT

00905322256473; aslidonmez@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 18, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): July 25, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

TU (1)