Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age2-12
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Children aged 2-12 years with ASA physical status I-II undergoing elective circumcision under general anesthesia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Measurement of Preoperative Inflammatory Biomarkers
Other interventionBlood 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.
Treatment groups
No treatment groups listed
Trial outcomes
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 postoperativelySecondary 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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov