Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section

Intracranial Pressure Increase Clinical Trial

Official title:

Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446013
• Other study ID #: 2020.05.1.16.048
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: September 2020
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal intubation and mechanical ventilation are components of general anesthesia. Endotracheal intubation has been shown to cause increased intracranial pressure. There is not enough information about the effect of spinal anesthesia on intracranial pressure during cesarean operations. Increased intracranial pressure can cause neurological complications by disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia method should be determined especially in pregnant patients who are at risk of increased intracranial pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 30, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Undergoing elective c-section operation

• Age between 18-49

• ASA I-II

• Gestational week = 36

Exclusion Criteria:

• Ophthalmologic disease and optic nerve pathology

• Increased intracranial pressure

• History of cerebrovascular disease

• Cases where spinal anesthesia is contraindicated

• Emergency cesarean category level 1

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase

Intervention

Other:
• Optic Nerve Sheath Diameter Measurement
The change in intracranial pressure via optic nerve sheath diameter measurement

Locations

Country	Name	City	State
Turkey	Bagcilar Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bäuerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28. — View Citation

Geeraerts T, Merceron S, Benhamou D, Vigué B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29. — View Citation

Yoshitani K, Kawaguchi M, Miura N, Okuno T, Kanoda T, Ohnishi Y, Kuro M. Effects of hemoglobin concentration, skull thickness, and the area of the cerebrospinal fluid layer on near-infrared spectroscopy measurements. Anesthesiology. 2007 Mar;106(3):458-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Optic Nerve Sheath Diameter	The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.	Throughout the surgery
Primary	Change in regional cerebral oxygen saturation	The change in regional cerebral oxygen saturation during c-section among 5 time point.	Throughout the surgery
Secondary	Perioperative Hemodynamic Parameters	Mean arterial pressure in mmHg	Throughout the surgery
Secondary	Perioperative Hemodynamic Parameters	Heart rate beat per minute	Throughout the surgery