Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate

NCT04539379 | Completed

• 1 other identifier: 6353
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Magnesium Sulfate; Labetalol

Keywords

magnesium sulfate, labetalol, severe preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Study Arms (2)

magnesium sulfate

ACTIVE COMPARATOR

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

labetolol

ACTIVE COMPARATOR

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

Interventions

Magnesium sulfate DRUG

intravenous infusion

magnesium sulfate

Labetolol DRUG

intravenous infusion

Also known as: (Trandate™,)

labetolol

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Singleton Pregnant female complicated with severe preeclampsia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• acceptance
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, 44519, Egypt

Location

Related Publications (1)

• Mowafy SMS, Medhat MM. Evaluation of intravenous infusion of labetalol versus magnesium sulfate on cerebral hemodynamics of preeclampsia patients with severe features using transcranial doppler. J Clin Monit Comput. 2023 Aug;37(4):951-961. doi: 10.1007/s10877-023-01006-4. Epub 2023 Apr 19.

  PMID: 37074522 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate; Labetalol

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Officials

• Howida A kamal, M.D

  zagazig U

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 7, 2020
• Study Start: October 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

EG (1)