Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

NCT ID: NCT07323485

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-10

Study Completion Date

2026-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Delirium Pediatric Anesthesia Inflammatory Biomarkers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Measurement of Preoperative Inflammatory Biomarkers

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmet Murat Gul

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmet Murat Gül

Role: CONTACT

00905071399560

Aslı Dönmez

Role: CONTACT

00905322256473

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmet Murat Gül

Role: primary

00905071399560

Asli Dönmez

Role: backup

00905322256473

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AEŞH-EK-2025-299

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.