Spinal Versus General Anesthesia in Open Simple Prostatectomy

Sponsor
Hitit University
Study ID
NCT07643415
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spinal anesthesia — PROCEDURE
    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.
  • General anesthesia — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Apr 29, 2026
Status verified
Jun 2026
Primary completion
Aug 15, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Spinal Anesthesia
    Participants allocated to this arm will receive spinal anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.
  • Active Comparator: General Anesthesia
    Participants allocated to this arm will receive general anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.

Primary Outcome Measure

Clinically Significant Postoperative Bleeding [ Time Frame: Within 72 hours after surgery ]

Central Contacts

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