Optic Nerve Sheath DiameterNCT04765397
Different Resectoscopes Effects to Optic Nerve Sheath Diameter
A study testing Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound in people with Optic Nerve Sheath Diameter, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Diameter
- What is being tested?
- Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 50-80
- ASA I-II
- Planned TUR-P operation
Who cannot join
- Heart or respiratory failure
- Koagülation diathesis
- Eyedisease related patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Bursa, 60160
About this study
Official title: 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.
Read the 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
- Being tested
- Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound
- Keywords
- Monopolar Resectoscope, Bipolar Resectoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of different resectoscope fluids on optic nerve diameter measured by ultrasoundProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: operation time 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start20 Jul 2018
- Primary completion20 Dec 2018
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve Sheath DiameterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Umran Karaca, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ümran K Karaca, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalTuğba O Onur, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalSeyda Ö Özgünay, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalSermin E Eminoglu, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalAyse Neslihan B Balkaya, MD, Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765397
- Sponsor's protocol ID
- Bursa Yüksek Ihtisas EAH
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bipolar and Monopolar Resectoscope Use on Optic Nerve Diameter in Transurethral Resection Procedures Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04765397
- Acronym / sponsor ID
- Bursa Yüksek Ihtisas EAH
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- Monopolar Resectoscope, Bipolar Resectoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Procedure: Effect of different resectoscope fluids on optic nerve diameter measured by ultrasoundPatients 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 B | Active comparator | Procedure: Effect of different resectoscope fluids on optic nerve diameter measured by ultrasoundPatients 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 50-80
- ASA I-II
- Planned TUR-P operation
Key exclusion criteria (3 listed)
- Heart or respiratory failure
- Koagülation diathesis
- Eyedisease related patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of different resectoscope fluids on optic nerve diameter measured by ultrasoundDuring 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. | Procedure or surgery | Group B, Group M |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ümran K Karaca, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Tuğba O Onur, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Seyda Ö Özgünay, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound in people with Optic Nerve Sheath Diameter, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve sheath diameter(mm) (time frame: operation time 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.