Perioperative GDNF as a Predictive Factor for Postoperative Delirium and Adverse Neurological Outcomes in Pediatric Surgery:a Single-center, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Postoperative Delirium
研究概览
简要总结
To observe the dynamic changes in serum levels of inflammatory cytokines (e.g., IL-6, TNF-α), Brain-Derived Neurotrophic Factor (BDNF), and Glial Cell Line-Derived Neurotrophic Factor (GDNF) during the perioperative period in pediatric patients undergoing Scheduled Laparoscopic Hernia Repair surgery, and to investigate their relationship with the occurrence of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD),and to compare the different influence between propofol and sevoflurane . The aim is to provide insights into the neurobiological mechanisms underlying these complications and to identify potential biomarkers for risk stratification.
详细描述
Clarify the Correlation Between Perioperative Changes in Inflammatory Factors, BDNF, and GDNF Levels and Postoperative delirium (POD) Blood and urine samples were collected from pediatric patients at three time points: 5 minutes before anesthesia induction (T0), 1 hour after surgery began (T1), and on the first postoperative day (T2). Serum levels of inflammatory factors (such as IL-6 and TNF-α) as well as brain-derived neurotrophic factor (BDNF) and glial cell line-derived neurotrophic factor (GDNF) were measured. The Richmond Agitation-Sedation Scale (RASS) was used to assess the children within 5-10 minutes after awakening from anesthesia. The RASS score ranges from +4 (combative agitation) to -5 (coma), comprising 10 levels, with higher scores indicating more agitated states and lower scores indicating deeper sedation. A score ≥+1 was defined as agitation. By comparing changes in inflammatory factors and neurotrophic factor levels across different time points, the association with the occurrence of postoperative agitation was analyzed.
Clarify the Correlation Between Perioperative Changes in Inflammatory Factors, BDNF, and GDNF Levels and Learning and Memory Abilities at Age 5 For the same cohort of children, based on blood and urine samples collected at the aforementioned time points (T0, T1, T2), concentrations of inflammatory factors (such as IL-6 and TNF-α), BDNF, and GDNF were measured. When the children reached 5 years of age, standardized neurocognitive assessment tools (such as the Wechsler Preschool and Primary Scale of Intelligence-IV [WPPSI-IV] or age-appropriate memory and learning function tests) were used to evaluate their learning and memory abilities. Statistical analysis was performed to explore the potential correlation between the dynamic changes in the aforementioned biomarkers during the perioperative period and cognitive function scores at age 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Aged 1-3 years; (2) American Society of Anesthesiologists (ASA) Physical Status Classification I-II; (3) Body Mass Index (BMI) 18-35 kg/m²; (4) Agreement to participate in the study and signed informed consent form.
排除标准
- •(1) Surgical duration exceeding 4 hours; (2) Patients with language or hearing impairments hindering effective communication; (3) Patients with postoperative infections or perioperative cardiopulmonary complications; (4) Patients with preoperative psychiatric disorders.
研究组 & 干预措施
Sevoflurane Group
Anesthesia was maintained with sevoflurane (Inhalation Sevoflurane, Brand: Kaiteli, Specification: 120 mL, Approval Number: National Drug Approval H20070172, Manufacturer: Shanghai Hengrui Pharmaceutical) combined with continuous intravenous infusion of remifentanil.
干预措施: Sevoflurane group (Drug)
Propofol Group
Anesthesia was maintained with remifentanil combined with continuous intravenous infusion of propofol at a maintenance dose of 0.5 mg/(kg·h).
干预措施: Propofol group (Drug)
结局指标
主要结局
Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Postoperative Delirium
时间窗: Preoperative to postoperative day 1
The levels of inflammatory factors IL-1β, IL-6, and TNF-α in pediatric patients will be measured using ELISA before surgery, 30 minutes during surgery, and one day after surgery. Simultaneously, the levels of neurotrophic factors BDNF and GDNF will be detected using ELISA. The RASS scale was employed to assess the level of emergence agitation in the children. A t-test will be used to compare whether the inflammatory factor levels between the two groups were correlated with the occurrence of emergence agitation, to determine whether the pre- and postoperative changes in neurotrophic factors are statistically significant, and to evaluate whether these changes is correlated with the incidence of emergence agitation.
Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Neurodevelopmental Outcomes at 5 Years of Age
时间窗: Preoperative until the child reaches 5 years of age
The levels of inflammatory factors IL-1β, IL-6, and TNF-α in pediatric patients will be measured using ELISA before surgery, 30 minutes during surgery, and one day after surgery. Simultaneously, the levels of neurotrophic factors BDNF and GDNF will be detected using ELISA. The Wechsler Scale II will be employed to assess the learning and memory abilities of the children at five years of age. A t-test was used to compare whether the inflammatory factor levels between the two groups will be correlated with the development of long-term learning and memory function, and to evaluate whether changes in these levels were associated with the occurrence of long-term learning and memory function.
次要结局
- Collection between Anesthetic Drugs on the Expression of Inflammatory Factors with Neurotrophic Factors(Intraoperative to postoperative day 1)
- Correlation between Surgical Type on the Expression of Inflammatory Factors with Neurotrophic Factors(Intraoperative to postoperative day 1)
- Correlation between Surgical Duration on the Expression of Inflammatory Factors with Neurotrophic Factors(Intraoperative to postoperative day 1)