Effect of Preoperative Inflammatory Biomarkers on Postoperative Delirium in Children Undergoing Circumcision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Incidence of Postoperative Delirium
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Postoperative Delirium
时间窗: 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.
次要结局
- Correlation between preoperative inflammatory biomarkers (NLR, PLR, SII, SIRI, MLR) and delirium severity (total PAED score).(Within 2 hours postoperatively)
研究者
Ahmet Murat Gul
Specialist
Ankara Etlik City Hospital