RecruitingNot ApplicableNCT07643415

Spinal Versus General Anesthesia in Open Simple Prostatectomy

Effect of Spinal Versus General Anesthesia on Postoperative Bleeding in Patients Undergoing Open Simple Prostatectomy: A Prospective Randomized Controlled Trial

Sponsor

Hitit University

Enrollment

80 participants

Start Date

Apr 29, 2026

Study Type

INTERVENTIONAL

Conditions

Anesthesia Urologic Neoplasms Benign Prostatic Hyperplasia

Summary

Open simple prostatectomy is still performed for selected patients with benign prostatic hyperplasia, particularly in cases with large prostate volume. Postoperative bleeding, hematuria, clot retention, and transfusion requirement are clinically important complications after this procedure. This prospective randomized controlled trial will compare the effects of spinal anesthesia and general anesthesia on postoperative bleeding in patients undergoing open simple prostatectomy. Participants will be randomized into two groups: spinal anesthesia or general anesthesia. Tranexamic acid or any additional hemostatic agent will not be used. Postoperative bleeding will be assessed using hemoglobin and hematocrit changes, transfusion requirement, hematuria, clot retention, need for bladder irrigation, and bleeding-related reintervention. The study aims to determine whether spinal anesthesia is associated with reduced postoperative bleeding compared with general anesthesia in open simple prostatectomy.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria5

Male patients aged 18 years or older.
Diagnosis of benign prostatic hyperplasia (BPH).
Scheduled to undergo open simple prostatectomy.
American Society of Anesthesiologists (ASA) physical status I-III.
Ability to provide written informed consent.

Exclusion Criteria8

Refusal or inability to provide informed consent.
Patients scheduled for radical prostatectomy due to prostate cancer.
Emergency surgery.
Known coagulation disorders or clinically significant thrombocytopenia.
Ongoing anticoagulant or antiplatelet therapy that cannot be discontinued according to institutional protocols.
Contraindication to spinal anesthesia.
Participation in another interventional clinical trial that may affect study outcomes.
Administration of tranexamic acid or any additional hemostatic agent during the perioperative period.

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Interventions

PROCEDURESpinal anesthesia

Spinal anesthesia will be performed at the L3-4 or L4-5 interspace under aseptic conditions using hyperbaric bupivacaine. Light sedation may be administered when clinically required.

PROCEDUREGeneral anesthesia

General anesthesia will be induced and maintained according to the institutional standard protocol. Airway management, mechanical ventilation, anesthetic maintenance, antiemetic prophylaxis, and multimodal analgesia will be applied according to routine clinical practice.