Different Resectoscopes Effects to Optic Nerve Sheath Diameter

The Effect of Bipolar and Monopolar Resectoscope Use on Optic Nerve Diameter in Transurethral Resection Procedures Under Spinal Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Optic Nerve Sheath Diameter
• Intervention / Treatment: Procedure: Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 60160
    • University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 50-80
• ASA I-II
• Planned TUR-P operation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optic nerve sheath diameter(mm)	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	operation time 3 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Study Chair: Tuğba O Onur, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Seyda Ö Özgünay, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Sermin E Eminoglu, MD, Bursa Yüksek İhtisas Education and Research Hospital; Study Chair: Ayse Neslihan B Balkaya, MD, Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2018
• Primary Completion (ACTUAL): December 20, 2018
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Monopolar Resectoscope; Bipolar Resectoscope
• Other Study ID Numbers: Bursa Yüksek Ihtisas EAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No