Effects of Spinal Versus General Anesthesia on Coagulation and Fibrinolysis in Patients Undergoing Transurethral Resection of the Prostate: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments
研究概览
简要总结
This prospective randomized clinical trial aims to compare the effects of spinal and general anesthesia on perioperative coagulation and fibrinolysis in patients undergoing elective transurethral resection of the prostate (TURP). Blood samples are collected before surgery and at 1 and 24 hours postoperatively to evaluate coagulation and fibrinolytic parameters. The study also assesses perioperative hemodynamic events and postoperative complications.
详细描述
Transurethral resection of the prostate (TURP) is one of the most commonly performed surgical procedures for benign prostatic hyperplasia. Surgical trauma activates both coagulation and fibrinolytic pathways, and prostate tissue possesses unique fibrinolytic properties due to its high concentration of plasminogen activators. The anesthetic technique may modify perioperative hemostasis through its effects on the neuroendocrine stress response.
The purpose of this prospective randomized study is to compare spinal anesthesia and general anesthesia with respect to perioperative and early postoperative changes in coagulation and fibrinolysis. Venous blood samples are obtained before surgery and at 1 and 24 hours after surgery for measurement of prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen concentration, and D-dimer levels.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients
- •Age ≥18 years
- •Scheduled for elective bipolar transurethral resection of the prostate
- •ASA physical status I-II
- •Ability to provide written informed consent
排除标准
- •History of deep vein thrombosis or pulmonary embolism
- •Known inherited or acquired coagulation disorder
- •Severe hepatic insufficiency
- •Severe renal insufficiency
- •Use of anticoagulants, antiplatelet drugs, or NSAIDs within 10 days before surgery
- •Platelet count <100 × 10⁹/L
- •INR >1.5
- •aPTT >47 seconds
- •Contraindications to spinal anesthesia
- •Prostate malignancy
- •ASA physical status III or higher
- •Refusal to participate
结局指标
主要结局
Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments
时间窗: Baseline, 1 hour after surgery, and 24 hours after surgery
Prothrombin time (PT) will be measured to evaluate perioperative changes in the extrinsic coagulation pathway. Unit of Measure: Seconds
Change in Activated Partial Thromboplastin Time (aPTT) from Baseline to Postoperative Assessments
时间窗: Baseline, 1 hour after surgery, and 24 hours after surgery
Activated partial thromboplastin time (aPTT) will be measured to evaluate changes in the intrinsic coagulation pathway. Units of measure: seconds
Change in International Normalized Ratio (INR) from Baseline to Postoperative Assessments
时间窗: Baseline, 1 hour after surgery, and 24 hours after surgery
INR will be measured as a standardized indicator of coagulation status. Unit of Measure: Ratio
Change in Fibrinogen Concentration from Baseline to Postoperative Assessments
时间窗: Baseline, 1 hour after surgery, and 24 hours after surgery
Plasma fibrinogen concentration will be measured to evaluate changes in coagulation activity. Unit of Measure: mg/dL
Change in D-dimer Concentration from Baseline to Postoperative Assessments
时间窗: Baseline, 1 hour after surgery, and 24 hours after surgery
Plasma D-dimer concentration will be measured to evaluate perioperative fibrinolytic activation. Unit of Measure: mg/L
次要结局
- Incidence of adverse events(From induction of anesthesia until completion of surgery.)
研究者
Sinan Uzman
Associate Professor of Anesthesiology and Reanimation
Haseki Training and Research Hospital