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CompletedNCT07323485Updated Aug 4, 2026

Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

An observational study in Postoperative Delirium, Pediatric Anesthesia and Inflammatory Biomarkers, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Ankara Etlik City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
2 Years to 12 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Postoperative Delirium
  • Pediatric Anesthesia
  • Inflammatory Biomarkers

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Keywords

  • Circumcision
  • Pediatric Anesthesia
  • Inflammatory Biomarkers
  • Postoperative Delirium
03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's enrollment of 140 is below the median of 164 across 280 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Ankara Etlik City Hospital is the lead sponsor of 166 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
Male
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (actual)
Patient registry
No

Interventions

  • OtherMeasurement 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.

06

What researchers measure

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.

    Time frame: Within 2 hours postoperatively

Secondary outcomes

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

    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.

    Time frame: Within 2 hours postoperatively

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Study locations

1 site
  • Ankara Etlik City Hospital
    Altındağ, Ankara, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07323485
Lead sponsor
Ankara Etlik City Hospital
Responsible party
Ahmet Murat Gul (Specialist, Ankara Etlik City Hospital) — Principal investigator
First posted
Jan 7, 2026
Start date
Jan 18, 2026
Primary completion
Jun 10, 2026
Completion
Jul 25, 2026
Last update
Aug 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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