Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate

Magnesium Sulfate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539379
• Other study ID #: 6353
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Magnesium Sulfate
• Pre-Eclampsia

Intervention

Drug:
• Magnesium sulfate
intravenous infusion
• Labetolol
intravenous infusion

Locations

Country	Name	City	State
Egypt	Faculty of Medicine,Zagazig University	Zagazig	Zagazig, Elsharkia,egypt

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	adverse effects of the study drugs	hypotension,Bradycardia,persistent hypertension	post-treatment till 24 hours