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

NCT03853889 | Unknown

• 1 other identifier: ABANTIBU 6
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracranial Pressure

Keywords

optic nerve sheath pressure; noninvasive intracranial pressure measurement; epidural anesthesia; cesarean

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

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.

Procedure: USG guided ONSD measurement preepidural

Interventions

USG guided ONSD measurement preepidural PROCEDURE

Measurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia

Also known as: USG guided ONSD measurement postepidural

post epidural ONSD; preepidural ONSD

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• epidural anesthesia patients
• years patients
• American Society of Anesthesiologists status I-II patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Officials

• murat bilgi, MD

  Bolu Abant İzzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

murat bilgi, MD

CONTACT

+90 05053745059; drmuratbilgi@gmail.com

murat bilgi, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 26, 2019
• Study Start: June 28, 2019
• Primary Completion: August 17, 2019
• Study Completion: December 17, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07