Clinical trial NCT05119101: Dexamedtomidine in Control of Intracranial Pressure in Preeclampsia
Official title: Dexamedtomidine as Adjuvant to Magnesium Sulphate for Intracranial Pressure Control in Pre-eclampsia: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Intracranial Pressure Control in Pre-eclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: 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.
timeFrame: till two hours after cesarian section
Secondary outcomes:
measure: 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
timeFrame: two hours after cesarian section
measure: o The difference in umbilical blood flow indices by Doppler.
timeFrame: two hours after cesarian section
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine Assiut University
Study officials:
affiliation: Assiut University
name: HossamElden G Fakhry, DR
role: PRINCIPAL_INVESTIGATOR
References: