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

NCT ID: NCT03853889

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2019-12-17

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

USG guided ONSD measurement preepidural

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

USG guided ONSD measurement preepidural

Intervention Type: PROCEDURE

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

Interventions

USG guided ONSD measurement preepidural

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

Intervention Type: PROCEDURE

Other Intervention Names

USG guided ONSD measurement postepidural

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Murat Bilgi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

murat bilgi, MD

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant İzzet Baysal University

Central Contacts

murat bilgi, MD

Role: CONTACT

drmuratbilgi@gmail.com

+90 05053745059

murat bilgi, MD

Role: CONTACT

Other Identifiers

ABANTIBU 6

Identifier Type: -

Identifier Source: org_study_id