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Spinal Versus General Anesthesia on Coagulation and Fibrinolysis During Transurethral Resection of the Prostate

2026年7月27日 更新者：Sinan Uzman、Haseki Training and Research Hospital

Effects of Spinal Versus General Anesthesia on Coagulation and Fibrinolysis in Patients Undergoing Transurethral Resection of the Prostate: A Prospective Randomized Study

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

78

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Istanbul
      • Istanbul、Istanbul、土耳其（türkiye）、34265
        • Sultangazi Haseki Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：spinal anesthesia
Participants received spinal anesthesia with hyperbaric bupivacaine for elective bipolar transurethral resection of the prostate (TURP).
程序：Spinal Anesthesia (bupivacaine)
Spinal anesthesia was performed at the L4-L5 interspace using 12.5 mg of hyperbaric bupivacaine for elective bipolar transurethral resection of the prostate (TURP). Standard intraoperative monitoring and perioperative management were applied.
有源比较器：general anesthesia
Participants received standardized general anesthesia for elective bipolar transurethral resection of the prostate (TURP).
程序：General Anaesthesia
General anesthesia was induced with intravenous propofol, fentanyl, and rocuronium, and maintained with sevoflurane. Standard intraoperative monitoring and perioperative management were applied during elective bipolar transurethral resection of the prostate (TURP).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments
大体时间：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
Baseline, 1 hour after surgery, and 24 hours after surgery
Change in Activated Partial Thromboplastin Time (aPTT) from Baseline to Postoperative Assessments
大体时间：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
Baseline, 1 hour after surgery, and 24 hours after surgery
Change in International Normalized Ratio (INR) from Baseline to Postoperative Assessments
大体时间：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
Baseline, 1 hour after surgery, and 24 hours after surgery
Change in Fibrinogen Concentration from Baseline to Postoperative Assessments
大体时间：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
Baseline, 1 hour after surgery, and 24 hours after surgery
Change in D-dimer Concentration from Baseline to Postoperative Assessments
大体时间：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
Baseline, 1 hour after surgery, and 24 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
Incidence of adverse events
大体时间：From induction of anesthesia until completion of surgery.
  • Hypotension
  • Hypertension
  • Bradycardia
  • Tachycardia
  • Cardiac arrhythmia
  • Hypoxemia
From induction of anesthesia until completion of surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Haseki Training and Research Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月10日

初级完成 (实际的)

2025年3月31日

研究完成 (实际的)

2025年3月31日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月27日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 18-2024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made publicly available.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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