Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

February 18, 2026 updated by: Ahmet Murat Gul, Ankara Etlik City Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Delirium
Time Frame: Within 2 hours postoperatively

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between preoperative inflammatory biomarkers (NLR, PLR, SII, SIRI, MLR) and delirium severity (total PAED score).
Time Frame: Within 2 hours postoperatively

The 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.
Within 2 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2026

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

July 25, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK-2025-299

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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