- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853889
Evaluation of the Effect on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section (EONSDCS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: murat bilgi, MD
- Phone Number: +90 05053745059
- Email: drmuratbilgi@gmail.com
Study Contact Backup
- Name: murat bilgi, MD
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- epidural anesthesia patients
- 18-40 years patients
- American Society of Anesthesiologists status I-II patients
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: preepidural ONSD
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.
|
Measurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia
Other Names:
|
Experimental: post epidural ONSD
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.
|
Measurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Basal(T0),Immediately after administration of epidural anesthesia(T1), after epidural anesthesia 15 min(T2), 30 min (T3),60 min (T4)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: murat bilgi, MD, Bolu Abant İzzet Baysal University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ABANTIBU 6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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