Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate

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

Sponsors

Lead Sponsor: Zagazig University

Source 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.

Overall Status Recruiting
Start Date April 1, 2020
Completion Date April 1, 2021
Primary Completion Date October 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
mean velocity basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
Secondary Outcome
Measure Time Frame
mean end diastolic velocity basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
pulsatility index basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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 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.
adverse effects of the study drugs post-treatment till 24 hours
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Magnesium sulfate

Description: intravenous infusion

Arm Group Label: magnesium sulfate

Intervention Type: Drug

Intervention Name: Labetolol

Description: intravenous infusion

Arm Group Label: labetolol

Other Name: (Trandate™,)

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.

Gender: Female

Gender Based: Yes

Gender Description: Singleton Pregnant female complicated with severe preeclampsia

Minimum Age: 21 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Howida A kamal, M.D Study Director zagazig U
Overall Contact

Last Name: marwa mohamed medhat, M.D

Phone: +201002828937

Email: [email protected]

Location
Facility: Status: Contact: Faculty of Medicine,Zagazig University Howida A Kamal, MD 01225096755 002 [email protected]
Location Countries

Egypt

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Zagazig University

Investigator Full Name: Marwa Mohamed Medhat

Investigator Title: lecture of anesthesia and surgical intensive care (Principal Investigator)

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: magnesium sulfate

Type: Active Comparator

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..

Label: labetolol

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov