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
Verified date | September 2020 |
Source | Bagcilar Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bagcilar Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bagcilar Training and Research Hospital |
Turkey,
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
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 |
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