Spinal Versus General Anesthesia in Open Simple Prostatectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorHitit University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Spinal anesthesia
Procedure/SurgerySpinal 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/SurgeryGeneral 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Spinal AnesthesiaActive comparator 1 intervention
Group B: General AnesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinically Significant Postoperative Bleeding
Clinically significant postoperative bleeding is defined as the occurrence of at least one of the following events: Requirement for red blood cell transfusion; Hemoglobin decrease ≥2 g/dL accompanied by persistent gross hematuria and/or ongoing bladder irrigation; Clot retention requiring intensified bladder irrigation or endoscopic clot evacuation; Bleeding-related reintervention.
Time frame
Within 72 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov