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EONSDCS: Evaluation of the Effect on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section

Sponsor
Abant Izzet Baysal University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03853889
Collaborator
(none)
35
Enrollment
2
Arms
5.7
Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: USG guided ONSD measurement preepidural
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of the Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section
Anticipated Study Start Date :
Jun 28, 2019
Anticipated Primary Completion Date :
Aug 17, 2019
Anticipated Study Completion Date :
Dec 17, 2019

Arms and Interventions

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.

Procedure: USG guided ONSD measurement preepidural
Measurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia
Other Names:
  • USG guided ONSD measurement postepidural

    		•
    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.

    Procedure: USG guided ONSD measurement preepidural
    Measurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia
    Other Names:
  • USG guided ONSD measurement postepidural

    		•

    Outcome Measures

    Primary Outcome Measures

    1. increase in the diameter of the optic nerve sheath after epidural anesthesia [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Abant Izzet Baysal University

    Investigators

    • Principal Investigator: murat bilgi, MD, Bolu Abant İzzet Baysal University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murat Bilgi, Principal Investigator, Abant Izzet Baysal University
    ClinicalTrials.gov Identifier:
    NCT03853889
    Other Study ID Numbers:
    • ABANTIBU 6
    First Posted:
    Feb 26, 2019
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Murat Bilgi, Principal Investigator, Abant Izzet Baysal University
    optic nerve sheath pressure
    noninvasive intracranial pressure measurement
    epidural anesthesia
    cesarean

    Study Results

    No Results Posted as of Jul 5, 2019