Evaluation of Preoperative and Postoperative Serum BDNF, IL-1β, and HMGB1 Levels and Cognitive Changes in Patients Undergoing General Anesthesia: Differences Between Patients With No Prior General Anesthesia and Those With Multiple Anesthesia Exposures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Change in Serum BDNF Levels
研究概览
简要总结
This prospective, observational study investigates the impact of repeated general anesthesia exposure on neuroinflammatory biomarkers and neurotrophic factors. The study will enroll 160 adult patients (aged 18-65 years) scheduled for elective cholecystectomy surgery, divided into two groups: patients with no previous general anesthesia exposure (n=80) and patients with at least one or more previous general anesthesia exposures (n=80).
Serum levels of Brain-Derived Neurotrophic Factor (BDNF), Interleukin-1 beta (IL-1β), and High Mobility Group Box 1 (HMGB1) will be measured using ELISA method at two time points: preoperatively (baseline) and 24 hours postoperatively. Cognitive function will also be assessed at both time points.
The primary objective is to evaluate whether multiple exposures to general anesthesia lead to significant differences in serum BDNF, IL-1β, and HMGB1 levels, reflecting changes in neurotrophic balance and neuroinflammatory response. This study aims to provide insights into the potential biochemical mechanisms underlying anesthesia-related cognitive changes and contribute original clinical data to the current literature on general anesthesia safety and neurobiological effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Scheduled for elective cholecystectomy surgery
- •Either no previous general anesthesia exposure OR at least one or more previous general anesthesia exposures
- •Ability to provide informed consent
- •American Society of Anesthesiologists (ASA) physical status I-II
排除标准
- •Chronic neurological diseases (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.)
- •Psychiatric illness requiring medication
- •Metabolic syndrome (diabetes mellitus, hypertension, cardiac disease)
- •Chronic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- •Corticosteroid or immunosuppressive therapy within the last 6 months
- •Patients requiring intensive care admission
- •Pregnancy or breastfeeding
- •Known allergy to anesthetic agents
- •Inability to provide informed consent
研究组 & 干预措施
No Previous General Anesthesia
Healthy volunteers aged 18-65 years who have never undergone general anesthesia. This control group will undergo elective cholecystectomy surgery under general anesthesia. Blood samples will be collected preoperatively and 24 hours postoperatively to measure serum BDNF, IL-1β, and HMGB1 levels. Cognitive function will also be assessed at both time points.
Previous General Anesthesia Exposure
Patients aged 18-65 years scheduled for elective cholecystectomy who have received general anesthesia at least once or multiple times in the past. Blood samples will be collected preoperatively and 24 hours postoperatively to measure serum BDNF, IL-1β, and HMGB1 levels. Cognitive function will also be assessed at both time points. This group will be compared with the control group to evaluate the impact of repeated anesthesia exposure on neuroinflammatory biomarkers and neurotrophic balance.
结局指标
主要结局
Change in Serum BDNF Levels
时间窗: Preoperative (baseline) and 24 hours postoperative
Change in serum Brain-Derived Neurotrophic Factor (BDNF) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours
Change in Serum HMGB1 Levels
时间窗: Preoperative (baseline) and 24 hours postoperative
Change in serum High Mobility Group Box 1 (HMGB1) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours
Change in Serum IL-1β Levels
时间窗: Preoperative (baseline) and 24 hours postoperative
Change in serum Interleukin-1 beta (IL-1β) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours
次要结局
- Correlation Between Biomarkers(At 24 hours postoperative)
- Comparison Between Single vs Multiple Anesthesia Exposure Groups(Preoperative (baseline) and 24 hours postoperative)