Dexamedtomidine as Adjuvant to Magnesium Sulphate for Intracranial Pressure Control in Pre-eclampsia: a Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Age: younger than 25 or older than
- •Pregnant females with mild preeclampsia.
- •Patients with cerebro-vascular diseases, Glaucoma, Hepatic failure, Renal failure .
- •patient who got their MgSO4 medication before the first reading of Optic nerve sheath diameter ONSD were also excluded.
- •History of allergy to dexamedotomidine.
研究组 & 干预措施
Magnesium sulphate
patients will recieve Mg sulphate as loading dose of 4 g diluted in 200 ml normal saline intravenous over 10 minutes followed by 1 g/h infusion for 24 h.
干预措施: Magnesium sulfate (Drug)
Dexamedotomidine adjuvant to Magnesium sulphate
Patients will reccieve Mg sulphate as loading dose of 4 g diluted in 200 ml normal saline intravenous over 10 minutes followed by 1 g/h infusion for 24 h. in addition they will receive an intravenous infusion of dexmedetomidine .5 μg/kg diluted in 200 ml normal saline intravenous over 10 minutes followed by .15 μg/kg/hr infusion for 24 h.
干预措施: Dexamedotomidine added to Magnesium sulfate (Drug)
结局指标
主要结局
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.
时间窗: till two hours after cesarian section
次要结局
- 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)
研究者
Hossam Elden Gamal Fakhry
Priniciple investigator
Assiut University