Intracranial Pressure Control in Pre-eclampsia
Conditions
Brief summary
The present study is designed to evaluate the differences in the effect of Mg sulphate alone and dexmedetomidine as an adjuvant to Mg sulphate on intracranial pressure when administered intravenously in cases of pre-eclampsia
Detailed description
Preeclampsia remains one of the leading causes of maternal morbidity and mortality in pregnant women. preeclampsia occurs in 7% to 8% of pregnancies. Preeclampsia is a multisystem progressive disorder characterized by the new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria after 20 weeks of gestation or postpartum. Preeclampsia is a potentially severe disease associated with maternal complications. Cerebral oedema is predominantly vasogenic and may be related to failure of cerebral autoregulation with subsequent hyperperfusion, blood brain barrier disruption, and endothelial cell dysfunction. The optic nerve with its dural sheath cover is considered a window to central nervous system. The subarachnoid space surrounds the optic nerve and communicates freely with the cerebral subarachnoid space. Changes in the optic nerve sheath diameter (ONSD) mirror the changes in the ICP as increases in the ONSD correlates with increase in the ICP. Magnesium sulphate (MgSO4) is a drug that is routinely used in the treatment of preeclampsia and prevention of eclamptic fits. Currently, several mechanisms have been proposed by researchers to explain the neuroprotective effect of MgSO4 .Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow.
Interventions
DRUGDexamedotomidine added to Magnesium sulfate
we will give dexamedotomidine and mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).
DRUGMagnesium sulfate
we will give mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
Female patients aged 25-43 and the gestational age above 34 weeks, with diagnostic preeclampsia (Hypertension and proteinuria) occurring after the 20th week of gestation and cesarian section is indicated with systolic blood pressure above 160 and diastolic blood pressure above 100.albumin in urine ++ or +++. No cardiac, hepatic,renal nor neurological problems.
Exclusion criteria
1. Age: younger than 25 or older than 43. 2. Pregnant females with mild preeclampsia. 3. Patients with cerebro-vascular diseases, Glaucoma, Hepatic failure, Renal failure . 4. patient who got their MgSO4 medication before the first reading of Optic nerve sheath diameter ONSD were also excluded. 5. History of allergy to dexamedotomidine. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| will be Optic nerve sheath diameter (ONSD) changes by using ultrasound as an indicator for changes in intracranial pressure in response to treatment with either mg sulphate alone or dexamedotomidine as an adjuvant to mg sulphate. | till two hours after cesarian section |
Secondary
| Measure | Time frame |
|---|---|
| o changes in levels of interleukin 6 (IL-6) in plasma before and after start of treatment in response to any change in brain activity | two hours after cesarian section |
| o The difference in umbilical blood flow indices by Doppler. | two hours after cesarian section |
Countries
Egypt
Contacts
Primary ContactHossam Elden G Fakhry, DR
Backup ContactMahmoud M Kamel, MD
Outcome results
None listed