Different Resectoscopes Effects to Optic Nerve Sheath Diameter

NCT ID: NCT04765397

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-20
• Study Completion Date: 2019-03-15

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.

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.

Conditions

Optic Nerve Sheath Diameter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Umran Karaca

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ümran K Karaca, MD

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Tuğba O Onur, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Seyda Ö Özgünay, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Sermin E Eminoglu, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Ayse Neslihan B Balkaya, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Bursa Yüksek Ihtisas EAH

Identifier Type: -

Identifier Source: org_study_id