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临床试验/NCT07214558
NCT07214558已完成不适用

he Effect of Spinal and General Anesthesia on Inflammatory Response Measured by Delta Neutrophil Index in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study

Elazıg Fethi Sekin Sehir Hastanesi1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Change in Delta Neutrophil Index (DNI)

研究概览

简要总结

This study aims to compare the effects of spinal versus general anesthesia on the inflammatory response measured by Delta Neutrophil Index (DNI) in patients undergoing total knee arthroplasty. The study is prospective and observational. A total of at least 84 patients will be included, with anesthesia type determined according to routine clinical practice. Preoperative and postoperative blood tests will be analyzed, and no additional blood samples will be required.

详细描述

This prospective observational study will be conducted at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation. Patients undergoing total knee arthroplasty will be assigned to two groups based on the anesthesia method used in routine practice: spinal anesthesia or general anesthesia. The primary outcome measure is the Delta Neutrophil Index (DNI), an inflammation marker automatically calculated by hematology analyzers using complete blood count parameters. DNI values will be compared preoperatively and postoperatively between groups. Additional data including age, sex, ASA classification, duration of surgery, hemogram parameters, and perioperative complications will be collected. The sample size calculation indicated that a minimum of 42 patients per group (total 84) are required to detect significant differences in DNI levels with 80% power at a 5% significance level. Statistical analyses will include Kolmogorov-Smirnov test for normality, independent t test or Mann-Whitney U test for between-group comparisons, and paired t test or Wilcoxon test for within-group comparisons. A p-value <0.05 will be considered statistically significant.

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

入选标准

  • Patients scheduled for total knee arthroplasty
  • Age ≥ 18 years
  • ASA physical status classification I-III

排除标准

  • Active infection
  • Hematologic disease (e.g., leukemia, aplastic anemia)
  • Autoimmune or chronic inflammatory disease
  • Use of corticosteroids or immunosuppressive drugs
  • Malignancy
  • Acute trauma or sepsis
  • Pregnancy

结局指标

主要结局

Change in Delta Neutrophil Index (DNI)

时间窗: From baseline (preoperative) to 24 hours postoperative.

Difference in DNI values measured preoperatively and postoperatively in patients undergoing total knee arthroplasty under spinal versus general anesthesia.

次要结局

  • Neutrophil Count(Preoperative to 24 hours postoperative.)
  • Perioperative Complications(Intraoperative and during hospital stay (up to 7 days).)
  • Operative Time(Intraoperative period.)
  • Lymphocyte Count(Preoperative to 24 hours postoperative.)
  • Neutrophil-to-Lymphocyte Ratio (NLR)(Preoperative to 24 hours postoperative.)

研究者

发起方
Elazıg Fethi Sekin Sehir Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevim Şenol Karataş

Principal Investigator

Elazıg Fethi Sekin Sehir Hastanesi

研究点 (1)

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