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

NCT07734233 | Completed

• 1 other identifier: 18-2024
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia; Transurethral Resection of the Prostate (TURP)

Keywords

Transurethral Resection of the Prostate (TURP); General Anesthesia; Spinal Anesthesia; Coagulation; Fibrinolysis; Fibrinogen; D-dimer; Hemostasis

Outcome Measures

Primary Outcomes (5)

• Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments

  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

  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

  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

  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

  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

Secondary Outcomes (1)

• Incidence of adverse events

  From induction of anesthesia until completion of surgery.

Study Arms (2)

spinal anesthesia

EXPERIMENTAL

Participants received spinal anesthesia with hyperbaric bupivacaine for elective bipolar transurethral resection of the prostate (TURP).

Procedure: Spinal Anesthesia (bupivacaine)

general anesthesia

ACTIVE COMPARATOR

Participants received standardized general anesthesia for elective bipolar transurethral resection of the prostate (TURP).

Procedure: General Anaesthesia

Interventions

Spinal Anesthesia (bupivacaine) PROCEDURE

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.

spinal anesthesia

General Anaesthesia PROCEDURE

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).

general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male participants were included because benign prostatic hyperplasia and transurethral resection of the prostate (TURP) are conditions and procedures specific to men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Sultangazi Haseki Training and Research Hospital

Istanbul, Istanbul, 34265, Turkey (Türkiye)

Location

Related Publications (1)

• Smyth R, Cheng D, Asokumar B, Chung F. Coagulopathies in patients after transurethral resection of the prostate: spinal versus general anesthesia. Anesth Analg. 1995 Oct;81(4):680-5. doi: 10.1097/00000539-199510000-00004.

  PMID: 7573993 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Thrombosis

Interventions

Anesthesia, Spinal; Bupivacaine; Anesthesia, General

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 29, 2026
• Study Start: October 10, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)