Intracranial PressureEONSDCSNCT03853889
Evaluation of the Effect on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section
A study testing USG guided ONSD measurement preepidural in people with Intracranial Pressure, run by Abant Izzet Baysal University.
Trial summary
Depending on the physiology of pregnancy, the risk of increased aspiration, difficult airway, increased oxygen consumption and reduced functional residual capacity, breathing problems make general anesthesia application risky. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure
- What is being tested?
- USG guided ONSD measurement preepidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2019to 17 Dec 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- epidural anesthesia patients
- 18-40 years patients
- American Society of Anesthesiologists status I-II patients
Who cannot join
- Patients with allergy to any of the drugs to be used in the study,
- patients with severe heart failure,
- atrial and ventricular arrhythmias,
- severe valve disease,
- electrolyte disorder,
- renal failure, preeclampsia, eclampsia
Trial locations and contacts
No sites are listed yet.
murat bilgi, MD contact
About this study
Official title: Evaluation of the Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section
Depending on the physiology of pregnancy, the risk of increased aspiration, difficult airway, increased oxygen consumption and reduced functional residual capacity, breathing problems make general anesthesia application risky. In obstetric operations, neuraxial anesthesia is preferred because of both maternal and maternal mortality and morbidity. Epidural area has decreased due to pregnancy physiology. Previous studies have shown that the blood given to the epidural area increases the intracranial pressure by compressing the dura mater.Optic nerve diameter measurements ultrasound guided is a non-invasive and reliable method for detecting intracranial pressure increase.
In this study, aimed to compare the optic nerve sheath diameter before and after epidural anesthesia with USG.
Read the detailed description
Epidural anesthesia will be performed at L2 level and sitting position in all patients. Patients will be measured and recorded for optic nerve sheath diameter at 15 min (T2), 30 min (T3) and 60 min (T4) immediately after epidural anesthesia (T0) and after epidural anesthesia.. Measurement of the optic nerve sheath diameter will be done with the help of a linear probe without applying high pressure to the eyeball while the patient is in supine position and the eyelids are closed. The optic nerve sheath diameter will be measured 3 mm beyond the optical disc. The measurements shall be applied in both transverse and sagittal planes for both eyes and the arithmetic mean of the four measured values.
- Conditions
- Intracranial Pressure
- Being tested
- USG guided ONSD measurement preepidural
- Keywords
- optic nerve sheath pressure, noninvasive intracranial pressure measurement, epidural anesthesia, cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG guided ONSD measurement preepiduralProcedure or surgery
Also called USG guided ONSD measurement postepidural
Measurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| preepidural ONSD | Active comparator | The diameter of the optic nerve sheath to be measured(ONSD) with the help of ultrasonography before epidural anesthesia(pre epidural ONSD). The measurement will be measured 3 mm behind the optical disc. The measurements shall be applied in both transverse and sagittal planes for both eyes and the arithmetic mean of the four measured values. Receives: Procedure: USG guided ONSD measurement preepidural |
| post epidural ONSD | Experimental | The diameter of the optic nerve sheath to be measured with the help of ultrasonography Immediately after epidural anesthesia(post epidural ONSD) (T1), 15 minutes (T2), 30 min (T3), 60. min (T4) epidural anesthesia. The measurement will be measured 3 mm behind the optical disc. The measurements shall be applied in both transverse and sagittal planes for both eyes and the arithmetic mean of the four measured values. Receives: Procedure: USG guided ONSD measurement preepidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in the diameter of the optic nerve sheath after epidural anesthesia
increase of intracranial pressure as a result of the administration of 20 ml of local anesthetic to the epidural area and its reflection on the diameter of the optic nerve sheath
Measured: Basal(T0),Immediately after administration of epidural anesthesia(T1), after epidural anesthesia 15 min(T2), 30 min (T3),60 min (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start28 Jun 2019 (estimated)
- Primary completion17 Aug 2019 (estimated)
- Study completion17 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Bilgi, Abant Izzet Baysal University
- Investigators
- murat bilgi, MD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853889
- Sponsor's protocol ID
- ABANTIBU 6
- Acronym
- EONSDCS
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT03853889
- Acronym / sponsor ID
- EONSDCS / ABANTIBU 6
- Conditions
- Intracranial Pressure
- Keywords
- optic nerve sheath pressure, noninvasive intracranial pressure measurement, epidural anesthesia, cesarean
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 28 Jun 2019 (estimated)
- Primary completion
- 17 Aug 2019 (estimated)
- Study completion
- 17 Dec 2019 (estimated)
- First posted
- 26 Feb 2019 (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.
Depending on the physiology of pregnancy, the risk of increased aspiration, difficult airway, increased oxygen consumption and reduced functional residual capacity, breathing problems make general anesthesia application risky. In obstetric operations, neuraxial anesthesia is preferred because of both maternal and maternal mortality and morbidity. Epidural area has decreased due to pregnancy physiology. Previous studies have shown that the blood given to the epidural area increases the intracranial pressure by compressing the dura mater.Optic nerve diameter measurements ultrasound guided is a non-invasive and reliable method for detecting intracranial pressure increase.
In this study, aimed to compare the optic nerve sheath diameter before and after epidural anesthesia with USG.
Detailed description
Epidural anesthesia will be performed at L2 level and sitting position in all patients. Patients will be measured and recorded for optic nerve sheath diameter at 15 min (T2), 30 min (T3) and 60 min (T4) immediately after epidural anesthesia (T0) and after epidural anesthesia.. Measurement of the optic nerve sheath diameter will be done with the help of a linear probe without applying high pressure to the eyeball while the patient is in supine position and the eyelids are closed. The optic nerve sheath diameter will be measured 3 mm beyond the optical disc. The measurements shall be applied in both transverse and sagittal planes for both eyes and the arithmetic mean of the four measured values.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preepidural ONSD | Active comparator | Procedure: USG guided ONSD measurement preepiduralThe diameter of the optic nerve sheath to be measured(ONSD) with the help of ultrasonography before epidural anesthesia(pre epidural ONSD). The measurement will be measured 3 mm behind the optical disc. The measurements shall be applied in both transverse and sagittal planes for both eyes and the arithmetic mean of the four measured values. |
| post epidural ONSD | Experimental | Procedure: USG guided ONSD measurement preepiduralThe diameter of the optic nerve sheath to be measured with the help of ultrasonography Immediately after epidural anesthesia(post epidural ONSD) (T1), 15 minutes (T2), 30 min (T3), 60. min (T4) epidural anesthesia. The measurement will be measured 3 mm behind the optical disc. The measurements shall be applied in both transverse and sagittal planes for both eyes and the arithmetic mean of the four measured values. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- epidural anesthesia patients
- 18-40 years patients
- American Society of Anesthesiologists status I-II patients
Key exclusion criteria (6 listed)
- Patients with allergy to any of the drugs to be used in the study,
- patients with severe heart failure,
- atrial and ventricular arrhythmias,
- severe valve disease,
- electrolyte disorder,
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 |
|---|---|---|
| USG guided ONSD measurement preepiduralAlso: USG guided ONSD measurement postepiduralMeasurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia | Procedure or surgery | post epidural ONSD, preepidural ONSD |
Primary outcome
increase in the diameter of the optic nerve sheath after epidural anesthesia
Time frame: Basal(T0),Immediately after administration of epidural anesthesia(T1), after epidural anesthesia 15 min(T2), 30 min (T3),60 min (T4)
increase of intracranial pressure as a result of the administration of 20 ml of local anesthetic to the epidural area and its reflection on the diameter of the optic nerve sheath
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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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.
murat bilgi, MD contact
murat bilgi, MD principal investigator
Abant Izzet Baysal University
Questions about this trial
What is this clinical trial studying?
A study testing USG guided ONSD measurement preepidural in people with Intracranial Pressure, run by Abant Izzet Baysal University.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact murat bilgi, MD (+90 05053745059, drmuratbilgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase in the diameter of the optic nerve sheath after epidural anesthesia (time frame: Basal(T0),Immediately after administration of epidural anesthesia(T1), after epidural anesthesia 15 min(T2), 30 min (T3),60 min (T4)). 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 5 Jul 2019.