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NCT Number: NCT07323485

Inflammatory Biomarkers and Postoperative Delirium in Pediatric 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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Inflammatory Biomarkers Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Anesthesia Postoperative Complications Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Murat Gül

CONTACT

[email protected]

00905071399560

Aslı Dönmez

CONTACT

[email protected]

00905322256473

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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