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

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

Study Overview

• Status: Completed
• Conditions: Magnesium Sulfate; Labetalol
• Intervention / Treatment: Drug: Magnesium sulfate; Drug: Labetolol

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Elsharkia,egypt
    • Zagazig, Zagazig, Elsharkia,egypt, Egypt, 44519
      • Faculty of Medicine,Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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..	Drug: Magnesium sulfate; intravenous infusion
Active Comparator: 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.	Drug: Labetolol; intravenous infusion; Other Names: (Trandate™,)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: Howida A kamal, M.D, zagazig U

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: magnesium sulfate, labetalol, severe preeclampsia
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: 6353 (Other Grant/Funding Number: FDA Office of Orphan Products Development (OOPD))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No