Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522295
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Assessment of Optic Nerve Sheath Diameter in Preeclamptic Pregnant Women Using Ultrasonography and Anesthetic Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Optic Nerve Sheath Diameter in Preeclamptic Pregnant Women Using Ultrasonography and Anesthetic Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Preeclampsia is a serious condition associated with complications such as pulmonary edema placental abruption hemolysis thrombocytopenia and cardiac renal and neurological complications occurring at a rate of 27-8 in pregnant women 12 Neurological complications are believed to be associated with reversible cerebral vasoconstriction syndrome 34 andor posterior leukoencephalopathy syndrome 456 sharing a common pathophysiology Cerebral edema is primarily vasogenic potentially linked to hyperperfusion resulting from impaired cerebral autoregulation blood-brain barrier disruption and endothelial cell dysfunction In some eclampsia cases computed tomography and magnetic resonance imaging may reveal signs consistent with significantly increased intracranial pressure ICP 7 However the true incidence of elevated ICP in preeclampsia is unknown clinical symptoms are nonspecific and interpretation especially during pregnancy and preeclampsia can be challenging 2
Cesarean section currently one of the most frequently performed surgeries worldwide is conducted in 211 of women 8 Anesthesia for cesarean section can be divided into neuraxial and general anesthesia The choice of anesthesia technique in conditions that may increase intracranial pressure such as cerebral edema may vary based on balancing risks and benefits Neuraxial analgesia and anesthesia are the first choice in healthy pregnancies but may be contraindicated in cases with intracranial lesions or increased bleeding risk 9 The presence of focal neurological deficits may favor general anesthesia for cesarean delivery 10 General anesthesia in these patients may result in an increased hemodynamic response to laryngoscopy Agents used in induction and maintenance can also affect cerebral autoregulation 11 Anesthesia induction and maintenance for these patients should be planned to minimize the increase in intracranial pressure
The optic nerve a part of the central nervous system is surrounded by a dural sheath and a subarachnoid space containing cerebrospinal fluid Three millimeters behind the ocular globe the optic nerve is solely surrounded by fat and the dural sheath can retract within its fatty environment particularly in conditions of increased pressure in the cerebrospinal fluid 2 Recent clinical studies have reported that ultrasonographic measurements of the optic nerve sheath diameter ONSD are correlated with increased intracranial pressure symptoms and may serve as a non-invasive reliable indicator of ICP 1213 Studies have reported high inter-observer reliability for ONSD measurements 1415 ONSD measurement is easy repeatable at the bedside rapid inexpensive and does not involve radiation
Compared to healthy pregnant women preeclamptic women are considered to have higher intracranial pressure during the childbirth process Anesthetic management for delivery in these women can be complex and controversial The aim of this study is to evaluate ultrasonographic measurements of optic nerve sheath diameter during the perioperative period independent of anesthesia management in healthy and preeclamptic pregnant women undergoing cesarean section We believe that these assessments will contribute to more reliable anesthesia planning for preeclamptic pregnancies
Cesarean section currently one of the most frequently performed surgeries worldwide is conducted in 211 of women 8 Anesthesia for cesarean section can be divided into neuraxial and general anesthesia The choice of anesthesia technique in conditions that may increase intracranial pressure such as cerebral edema may vary based on balancing risks and benefits Neuraxial analgesia and anesthesia are the first choice in healthy pregnancies but may be contraindicated in cases with intracranial lesions or increased bleeding risk 9 The presence of focal neurological deficits may favor general anesthesia for cesarean delivery 10 General anesthesia in these patients may result in an increased hemodynamic response to laryngoscopy Agents used in induction and maintenance can also affect cerebral autoregulation 11 Anesthesia induction and maintenance for these patients should be planned to minimize the increase in intracranial pressure
The optic nerve a part of the central nervous system is surrounded by a dural sheath and a subarachnoid space containing cerebrospinal fluid Three millimeters behind the ocular globe the optic nerve is solely surrounded by fat and the dural sheath can retract within its fatty environment particularly in conditions of increased pressure in the cerebrospinal fluid 2 Recent clinical studies have reported that ultrasonographic measurements of the optic nerve sheath diameter ONSD are correlated with increased intracranial pressure symptoms and may serve as a non-invasive reliable indicator of ICP 1213 Studies have reported high inter-observer reliability for ONSD measurements 1415 ONSD measurement is easy repeatable at the bedside rapid inexpensive and does not involve radiation
Compared to healthy pregnant women preeclamptic women are considered to have higher intracranial pressure during the childbirth process Anesthetic management for delivery in these women can be complex and controversial The aim of this study is to evaluate ultrasonographic measurements of optic nerve sheath diameter during the perioperative period independent of anesthesia management in healthy and preeclamptic pregnant women undergoing cesarean section We believe that these assessments will contribute to more reliable anesthesia planning for preeclamptic pregnancies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None