Postoperative DeliriumNCT07323485
Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision
An observational study of Postoperative Delirium and Pediatric Anesthesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium, Pediatric Anesthesia, Inflammatory Biomarkers
- What is being tested?
- Measurement of Preoperative Inflammatory Biomarkers
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2026to 25 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Children aged 2-12 years with ASA physical status I-II undergoing elective circumcision under general anesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Measurement of Preoperative Inflammatory Biomarkers
- Keywords
- Circumcision, Pediatric Anesthesia, Inflammatory Biomarkers, Postoperative Delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Preoperative Inflammatory BiomarkersOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start18 Jan 2026
- Primary completion10 Jun 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Murat Gul, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323485
- Sponsor's protocol ID
- AEŞH-EK-2025-299
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Inflammatory Biomarkers on Postoperative Delirium in Children Undergoing Circumcision
- ClinicalTrials.gov ID
- NCT07323485
- Acronym / sponsor ID
- AEŞH-EK-2025-299
- Keywords
- Circumcision, Pediatric Anesthesia, Inflammatory Biomarkers, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-12 years with ASA physical status I-II undergoing elective circumcision under general anesthesia.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Preoperative Inflammatory BiomarkersBlood 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Correlation between preoperative inflammatory biomarkers (NLR, PLR, SII, SIRI, MLR) and delirium severity (total PAED score).
Time frame: Within 2 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Pediatric Anesthesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (time frame: Within 2 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.