Effects of Spinal Versus General Anesthesia on Perioperative Inflammatory Response in Percutaneous Nephrolithotomy (PCNL): The Role of Neutrophil-to-Lymphocyte Ratio (NLR), Red Cell Distribution Width (RDW), and Lactate-to-Albumin Ratio (LAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Neutrophil-to-Lymphocyte Ratio (ΔNLR)
研究概览
简要总结
This observational study compares the effects of spinal versus general anesthesia on the perioperative systemic inflammatory response in adults undergoing PCNL. Routine clinical laboratory values (NLR, RDW, LAR) obtained preoperatively and postoperatively will be recorded to evaluate between-group and within-group changes. No additional blood sampling will be performed beyond standard care.
详细描述
The study will be conducted at the Department of Anesthesiology and Reanimation, Elazığ Fethi Sekin City Hospital, among adult patients scheduled for PCNL (ASA I-III). The anesthesia type (spinal vs general) is determined by clinical requirements; investigators do not influence this choice.
Sampling windows:
Preoperative: within ≤6 hours before surgery
Postoperative: first sample obtained within 6-24 hours after surgery Parameters: NLR (neutrophil/lymphocyte), RDW, LAR; plus age, sex, ASA class, operative time, and in-hospital complications.
Statistics: Normality testing; between-group comparisons by independent t-test or Mann-Whitney U; within-group by paired t-test or Wilcoxon; categorical by chi-square; p<0.05 significant. Power considerations target ≥45 per group (total ≥90). No extra biospecimens will be collected beyond routine care.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •ASA physical status I-III
- •Scheduled for percutaneous nephrolithotomy (PCNL)
- •Provided informed consent
排除标准
- •Active infection or sepsis
- •Known malignancy
- •Chronic inflammatory or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- •Current immunosuppressive therapy
结局指标
主要结局
Change in Neutrophil-to-Lymphocyte Ratio (ΔNLR)
时间窗: Baseline (≤6 hours preoperative) and 24 hours postoperatively
Difference in neutrophil-to-lymphocyte ratio (NLR) between preoperative (≤6 hours before surgery) and postoperative (6-24 hours after surgery) blood samples in spinal vs general anesthesia groups.
次要结局
- Change in Red Cell Distribution Width (ΔRDW)(Baseline (≤6 hours preoperative) and 24 hours postoperatively)
- Change in Lactate-to-Albumin Ratio (ΔLAR)(aseline (≤6 hours preoperative) and 24 hours postoperatively)
- Postoperative Complications(From surgery until hospital discharge (up to 7 days))
研究者
Sevim Şenol Karataş
Principal Investigator,
Elazıg Fethi Sekin Sehir Hastanesi