Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mean velocity
研究概览
简要总结
the purpose of this study is to compare Intravenous infusion of Labetalol versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients using Transcranial Doppler
详细描述
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 30 patients , (Group M) : will be given intravenous infusion of magnesium sulfate at a dose of 4 gm intravenously over 20 min as a loading dose then MgSO4 intravenous infusion is continued at a rate of 1 gm/h for 24 h or until obtain and stabilize the targeted blood pressure..
(Group L) : The patients will be given intravenous infusion of labetalol (Trandate™,) available in 20 ml ampoules containing 100mg labetalol (5mg/ml). Starting the infusion with 20mg/h and then titrate to obtain and stabilize the targeted blood pressure by adjusting the infusion as required every 15 - 30min to a maximum dose of 160mg/hr.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •acceptance
- •21 to 45 years old.
- •mass index ≤ 35 kg/m
- •Singleton Pregnant female complicated with severe preeclampsia
- •Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg on two occasions at least 4 hours apart
- •Thrombocytopenia (platelet count less than 100,000 )
- •Impaired liver function indicated by elevated liver enzymes (to twice the upper limit normal concentration), and severe persistent right upper quadrant or epigastric pain not responding to medications and not explained by another diagnosis.
- •Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or doubling of the serum creatinine concentration in the absence of other renal disease)
- •Pulmonary edema
- •New-onset headache unresponsive to medications and not accounted for by alternative diagnoses
- •Visual disturbances.
排除标准
- •Preexisting heart disease
- •Known pulmonary disorders.
- •Inadequate temporal window.
- •Atrial fibrillation and any rhythm abnormality.
- •History of allergy or contraindications to either magnesium sulfate or labetolol.
- •Exposure to any of the study medications within 24 hours of enrollment.
研究组 & 干预措施
magnesium sulfate
intravenous infusion of magnesium sulfate at a dose of 4 gm intravenously over 20 min as a loading dose then MgSO4 intravenous infusion is continued at a rate of 1 gm/h for 24 h or until obtain and stabilize the targeted blood pressure..
干预措施: Magnesium sulfate (Drug)
labetolol
The patients will be given intravenous infusion of labetolol (Trandate™, 5mg/ml) available in 20 ml ampoules containing 100mg labetalol (5mg/ml). Starting the infusion with 20mg/h and then titrate to obtain and stabilize the targeted blood pressure by adjusting the infusion as required every 15 - 30min to a maximum dose of 160mg/hr.
干预措施: Labetolol (Drug)
结局指标
主要结局
mean velocity
时间窗: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
mean velocity of middle cerebral artery
次要结局
- cerebral perfusion pressure(basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.)
- adverse effects of the study drugs(post-treatment till 24 hours)
- pulsatility index(basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.)
- occurrence of seizures(basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.)
- The need for other antihypertensive drugs(post-treatment one and six hours after drug administration.)
- mean end diastolic velocity(basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.)
研究者
Marwa Mohamed Medhat
lecture of anesthesia and surgical intensive care (Principal Investigator)
Zagazig University