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

Intracranial Pressure Clinical Trial

— EONSDCS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03853889
• Other study ID #: ABANTIBU 6
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: July 2019
• Source: Abant Izzet Baysal University
• Contact: murat bilgi, MD
• Phone: +90 05053745059
• Email: drmuratbilgi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 17, 2019
• Est. primary completion date: August 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Pressure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)