Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate (TURP)
Conditions
Keywords
Transurethral Resection of the Prostate (TURP), General Anesthesia, Spinal Anesthesia, Coagulation, Fibrinolysis, Fibrinogen, D-dimer, Hemostasis
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESpinal 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.
PROCEDUREGeneral 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).
Sponsors
Haseki Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in a 1:1 ratio to either spinal anesthesia or general anesthesia, and outcomes were compared between the two parallel groups.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | From induction of anesthesia until completion of surgery. | * Hypotension * Hypertension * Bradycardia * Tachycardia * Cardiac arrhythmia * Hypoxemia |
Countries
Turkey (Türkiye)
Outcome results
None listed