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: Unknown
• Conditions: Intracranial Pressure
• Intervention / Treatment: Procedure: USG guided ONSD measurement preepidural

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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)

Number of Arms

2

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.	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

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	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: Abant Izzet Baysal University
• Investigators: Principal Investigator: murat bilgi, MD, Bolu abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 28, 2019
• Primary Completion (Anticipated): August 17, 2019
• Study Completion (Anticipated): December 17, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: cesarean; epidural anesthesia; optic nerve sheath pressure; noninvasive intracranial pressure measurement
• Other Study ID Numbers: ABANTIBU 6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No