Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia

Study Overview
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Brief Summary
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Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.

Official Title
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How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study

Conditions
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Preeclampsia Severe

Intervention / Treatment
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* Diagnostic Test: optic nerve sheath measurement and transcranial doppler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged up to 18 years patient with severe preeclampsia defined by Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of amenorrhea, associated with neurologic troubles, eclampsia of epigastric pain. Decision by clinician to introduce an antihypertensive therapy by oral route : either labetalol or nicardipine Exclusion Criteria: history of intracranial expansive processus, surgery or vascular disease infectious state on probe placement unilateral anophthalmia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Labetalol<br>Patients who will receive labetalol in IV route in first intention | Diagnostic Test: optic nerve sheath measurement and transcranial doppler<br>* evaluation of cerebral hemodynamics through measurement of systolic and diastolic velocities and PI in middle cerebral artery. Intracranial pressure will be appreciate by optic nerve sheath value<br>|
| Nicardipine<br>Patients who will receive nicardipine in IV route in first intention | Diagnostic Test: optic nerve sheath measurement and transcranial doppler<br>* evaluation of cerebral hemodynamics through measurement of systolic and diastolic velocities and PI in middle cerebral artery. Intracranial pressure will be appreciate by optic nerve sheath value<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol. | Variation of values will be studied during a 2 hour time period, starting just before administration of either labetalol or nicardipine by i.v. route | just before treatment and 2 hours after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route | values are obtained by transcranial doppler | just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours | 
| variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route | values are obtained by transcranial doppler | just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours | 
| proportion of pathologic PI in middle cerebral artery in each group | values are obtained by transcranial doppler | just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours | 
| proportion of optic nerve sheath up to 5.8 mm in each group | values are obtained by ultrasonography | just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours | 
| values of optic nerve sheath diameter in each group | values are obtained by ultrasonography | At 30 minutes to 60 minutes and 6 hours to 8 hours |