Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler

Conditions
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Magnesium Sulfate, Labetalol

Intervention / Treatment
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* Drug: Magnesium sulfate
* Drug: Labetolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acceptance 21 to 45 years old. mass index ≤ 35 kg/m2. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: magnesium sulfate<br>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.. | Drug: Magnesium sulfate<br>* intravenous infusion<br>|
| Active Comparator: labetolol<br>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. | Drug: Labetolol<br>* intravenous infusion<br>* Other names: (Trandate™,);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean velocity | mean velocity of middle cerebral artery | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean end diastolic velocity | mean end diastolic velocity of middle cerebral artery | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | 
| pulsatility index | pulsatility index of middle cerebral artery | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | 
| cerebral perfusion pressure | cerebral perfusion pressure | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | 
| occurrence of seizures | 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 | The need for other antihypertensive drugs (nifidibine, nitroglycerine, hydralazine, etc) | post-treatment one and six hours after drug administration. | 
| adverse effects of the study drugs | hypotension,Bradycardia,persistent hypertension | post-treatment till 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium sulfate, labetalol, severe preeclampsia