Different Resectoscopes Effects to Optic Nerve Sheath Diameter

NCT04765397 | Completed

• 1 other identifier: Bursa Yüksek Ihtisas EAH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Optic Nerve Sheath Diameter

Keywords

Monopolar Resectoscope; Bipolar Resectoscope

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group M

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Interventions

Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound PROCEDURE

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.

Group B; Group M

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, 60160, Turkey (Türkiye)

Location

Study Officials

• Ümran K Karaca, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Tuğba O Onur, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Seyda Ö Özgünay, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Sermin E Eminoglu, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Ayse Neslihan B Balkaya, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: According to the resectoscopes used during the operation, patients will be divided into 2 groups as Monopolar one (Group M) and Bipolar one (Group B).

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: July 20, 2018
• Primary Completion: December 20, 2018
• Study Completion: March 15, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)