Labetalol, Magnesium Sulfate
Conditions
Keywords
magnesium sulfate, labetalol, severe preeclampsia
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.
Interventions
DRUGMagnesium sulfate
intravenous infusion
DRUGLabetolol
intravenous infusion
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| adverse effects of the study drugs | post-treatment till 24 hours | hypotension,Bradycardia,persistent hypertension |
| 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 |
Countries
Egypt
Outcome results
None listed