Different Resectoscopes Effects to Optic Nerve Sheath Diameter

Overview

In this study, in patients with benign prostatic hypertrophy, monopolar and transurethral prostate using bipolar techniques in resection; serum electrolytes in the perioperative period, osmolarity can occur in hemodynamic parameters the effect of changes on optic nerve diameter by ultrasonography.

Full Title of Study: “The Effect of Bipolar and Monopolar Resectoscope Use on Optic Nerve Diameter in Transurethral Resection Procedures Under Spinal Anesthesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 20, 2018

Detailed Description

This study is for TURP operation for Benign Prostate Hypertrophy patients. When patient comes to the operating room, routine preparations will be made. Haemodynamic parameters and over-the-eye with Optic nerve diameter will be checked with ultrasound before and 10 minutes after spinal anesthesia. Monopolar for patients according to the preference of the surgical team resectoscope technique or bipolar resectoscope technique will be applied. During the operation Blood pressure, pulse minute the number of irrigation solutions used and the amount of intravenously administered serum, operation time will be saved. Optic nerve sheath diameter after the operation would be checked again. intraoperative and postoperative complications in the waking room (respiratory distress, hypotension, hypertension, bradycardia, tachycardia, vomiting, headache, restlessness, seizure, arrhythmia, vision disorder) will be recorded.

Interventions

  • Procedure: Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound
    • During the operation Blood pressure, pulse minute the number of irrigation solutions used, and intravenous serum amounts, operation time will be saved. If there is an abnormal parameters or increased optic nerve sheath surgical team will be informed.

Arms, Groups and Cohorts

  • Active Comparator: Group M
    • Patients are in this group with monopolar technique according to the resectoscope technique used by the surgeon.Demographic data of the patients, mean arterial pressure (MAP), pulse minute number (NDS), peripheral oxygen saturation (SpO2), irrigation and intravenous fluid amounts, operation times, serum electrolytes (Na +, K +) and hemoglobin levels were analyzed and recorded.
  • Active Comparator: Group B
    • Patients are in this group with bipolar technique according to the resectoscope technique used by the surgeon.Demographic data of the patients, mean arterial pressure (MAP), pulse minute number (NDS), peripheral oxygen saturation (SpO2), irrigation and intravenous fluid amounts, operation times, serum electrolytes (Na +, K +) and hemoglobin levels were analyzed and recorded.

Clinical Trial Outcome Measures

Primary Measures

  • optic nerve sheath diameter(mm)
    • Time Frame: operation time 3 hours
    • A linear 10-5 MHz ultrasound probe (GE Healthcare Logiqe Series) was held on the upper eyelid over the gel carefully. Part of the optical nerve that enters the orbital globe was monitorized in the 2D mode without exerting much pressure. Diameter of the optic nerve sheath was measured 3 mm behind the optic disk using an electronic caliper after the right contrast was found between the retrobulber echogenic fatty tissue and the vertical hypoechogenic band

Participating in This Clinical Trial

Inclusion Criteria

  • Ages 50-80 – ASA I-II – Planned TUR-P operation Exclusion Criteria:

  • Heart or respiratory failure – Koagülation diathesis – Eyedisease related patients

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bursa Yüksek İhtisas Education and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Umran Karaca, Medical Doctor – Bursa Yüksek İhtisas Education and Research Hospital
  • Overall Official(s)
    • Ümran K Karaca, MD, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
    • Tuğba O Onur, MD, Study Chair, Bursa Yüksek İhtisas Education and Research Hospital
    • Seyda Ö Özgünay, MD, Study Chair, Bursa Yüksek İhtisas Education and Research Hospital
    • Sermin E Eminoglu, MD, Study Chair, Bursa Yüksek İhtisas Education and Research Hospital
    • Ayse Neslihan B Balkaya, MD, Study Chair, Bursa Yüksek İhtisas Education and Research Hospital

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