Clinical trial NCT04446013: Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section
Official title: Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Pressure Increase
Keywords: optic nerve sheath diameter
intracranial pressure
intraabdominal pressure
cerebral regional oxygen saturation
c-section
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-24
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Optic Nerve Sheath Diameter
timeFrame: Throughout the surgery
measure: Change in regional cerebral oxygen saturation
timeFrame: Throughout the surgery
Secondary outcomes:
measure: Perioperative Hemodynamic Parameters
timeFrame: Throughout the surgery
measure: Perioperative Hemodynamic Parameters
timeFrame: Throughout the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training and Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Mehmet Can Tunalı
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geeraerts T, Merceron S, Benhamou D, Vigue 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.
citation: Bauerle 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.
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. doi: 10.1097/00000542-200703000-00009.