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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04765397
Other study ID # Bursa Yüksek Ihtisas EAH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2018
Est. completion date March 15, 2019

Study information

Verified date February 2021
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 15, 2019
Est. primary completion date December 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Ages 50-80 - ASA I-II - Planned TUR-P operation Exclusion Criteria: - Heart or respiratory failure - Koagülation diathesis - Eyedisease related patients

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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