Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate
- Conditions
- Magnesium SulfateLabetalol
- Interventions
- Registration Number
- NCT04539379
- Lead Sponsor
- Zagazig University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description magnesium sulfate 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.. labetolol 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.
- Primary Outcome Measures
Name Time Method mean velocity 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
- Secondary Outcome Measures
Name Time Method cerebral perfusion pressure basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. cerebral perfusion pressure
adverse effects of the study drugs post-treatment till 24 hours hypotension,Bradycardia,persistent hypertension
pulsatility index basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. pulsatility index of middle cerebral artery
occurrence of seizures basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. occurrence of seizures
The need for other antihypertensive drugs post-treatment one and six hours after drug administration. The need for other antihypertensive drugs (nifidibine, nitroglycerine, hydralazine, etc)
mean end diastolic velocity basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. mean end diastolic velocity of middle cerebral artery
Trial Locations
- Locations (1)
Faculty of Medicine,Zagazig University
🇪🇬Zagazig, Zagazig, Elsharkia,egypt, Egypt