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Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes

ConditionIntra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age40+
SponsorBenha University

About this trial

Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate: Exploring Its Role in Optimizing Surgical Outcomes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indication for Prostate Surgery or Procedure - Patients undergoing transurethral resection of the prostate (TURP)

Prostate from 80 to 100 gm

Failed medical therapy

Disqualifiers

Uncontrolled Hypertension - Patients with significantly high blood pressure despite medication therapy.

Unstable angina, recent myocardial infarction, arrhythmias, or severe heart failure.

Significant Coagulopathy - Patients with bleeding disorders or on anticoagulants where excessive vasoconstriction may lead to tissue necrosis or inadequate perfusion

Hyperthyroidism, Pheochromocytoma or Endocrine Disorders - Patients with catecholamine-secreting tumors or other conditions that can lead to excessive sympathetic stimulation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TURP

    Device

    Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate

  • Epinephrine

    Drug

    Intra-Prostatic epinephrine injection in Bipolar Transurethral resection of large prostate

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Epinephrine injectionActive comparator 2 interventions
Group B: saline injectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative blood loss , need of blood transfusion

assessment of Blood Loss (Irrigation Fluid Hb Concentration): Bladder irrigation will be maintained for 24 hours post operatively, with fluid collections made at three intervals: Immediately postsurgery (V1), 6 hours postoperation (V2), and 24 hours postoperation (V3). The total volume collected will be measured, and 5000U of heparin will be added to each irrigation fluid container to prevent coagulation. After thorough mixing, 5-mL samples will be extracted and analyzed using cyanide met hemoglobin spectrophotometry at 540 nm to determine the Hb concentration. Blood loss will be estimated using specific formulas: (1) Hb concentration in irrigation fluid (g/L) = absorbance of fluid × 367.7; (2) Bleeding volume (mL) = (Hb concentration in irrigation fluid (g/L) × rinse volume (mL)) / preoperative Hb concentration(g/L).

Time frame
24h post operative

Secondary outcomes

1

Prostate volume , post voiding residual urine

prostate volume \& post voiding residual urine will be measured by Transrectal ultrasound

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov
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