Back to resultsEvaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate
Primary Purpose
Magnesium Sulfate, Labetalol
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium sulfate
Labetolol
Sponsored by
About this trial
This is an interventional treatment trial for Magnesium Sulfate focused on measuring magnesium sulfate, labetalol, severe preeclampsia
Eligibility Criteria
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.
Sites / Locations
- Faculty of Medicine,Zagazig University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
magnesium sulfate
labetolol
Arm Description
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..
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.
Outcomes
Primary Outcome Measures
mean velocity
mean velocity of middle cerebral artery
Secondary Outcome Measures
mean end diastolic velocity
mean end diastolic velocity of middle cerebral artery
pulsatility index
pulsatility index of middle cerebral artery
cerebral perfusion pressure
cerebral perfusion pressure
occurrence of seizures
occurrence of seizures
The need for other antihypertensive drugs
The need for other antihypertensive drugs (nifidibine, nitroglycerine, hydralazine, etc)
adverse effects of the study drugs
hypotension,Bradycardia,persistent hypertension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04539379
Brief Title
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate
Official Title
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnesium Sulfate, Labetalol
Keywords
magnesium sulfate, labetalol, severe preeclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
magnesium sulfate
Arm Type
Active Comparator
Arm Description
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..
Arm Title
labetolol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Labetolol
Other Intervention Name(s)
(Trandate™,)
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
mean velocity
Description
mean velocity of middle cerebral artery
Time Frame
basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
Secondary Outcome Measure Information:
Title
mean end diastolic velocity
Description
mean end diastolic velocity of middle cerebral artery
Time Frame
basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
Title
pulsatility index
Description
pulsatility index of middle cerebral artery
Time Frame
basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
Title
cerebral perfusion pressure
Description
cerebral perfusion pressure
Time Frame
basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
Title
occurrence of seizures
Description
occurrence of seizures
Time Frame
basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
Title
The need for other antihypertensive drugs
Description
The need for other antihypertensive drugs (nifidibine, nitroglycerine, hydralazine, etc)
Time Frame
post-treatment one and six hours after drug administration.
Title
adverse effects of the study drugs
Description
hypotension,Bradycardia,persistent hypertension
Time Frame
post-treatment till 24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Singleton Pregnant female complicated with severe preeclampsia
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howida A kamal, M.D
Organizational Affiliation
zagazig U
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine,Zagazig University
City
Zagazig
State/Province
Zagazig, Elsharkia,egypt
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
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Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate
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