Different Resectoscopes Effects to Optic Nerve Sheath Diameter

February 18, 2021 updated by: Umran Karaca, Bursa Yüksek İhtisas Education and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 60160
        • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
operation time 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bursa Yüksek İhtisas Education and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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