A Randomized Controlled Open Label Prospective Study to Assess Efficacy and Safety of Intravenous Labetalol Vs Intravenous Glyceryl Trinitrate in the Management of Hypertensive Crisis

1. BACKGROUND OF PRESENT STUDY:

Hypertensive crisis is a severe form of hypertension, characterized by a systolic blood pressure ≥180mm Hg or a diastolic blood pressure ≥120mm Hg. Hypertensive crisis is associated with high risk of mortality if left untreated, and current guidelines recommend reducing the mean arterial blood pressure (MABP) by 25% within 1 to 2 hours to manage the same. Intravenous Labetalol and intravenous nitro- glycerine (GTN) are amongst the most commonly prescribed agents to control hypertensive crisis. But there is lack of clear-cut recommendation regarding which one among these two drugs should be preferred over the other in this situation.

  2.OBJECTIVES OF PROPOSED RESEARCH:

To compare the Efficacy and safety of intravenous Labetalol with intravenous Glyceryl trinitrate in the management of hypertensive crisis.

  3.METHODOLOGY:

After obtaining Institutional Ethics Committee approval, screening of hypertensive patients according to inclusion and exclusion criteria will be done. Written informed consent of every patient will be taken and patients will be randomly allocated to the study groups. First group with 34 patients will receive intravenous Labetalol and second group with 34 patients will receive intravenous infusion of Glyceryl trinitrate. The outcomes like systolic blood pressure (SBP) and diastolic blood pressure (DBP), vital signs, any adverse events etc will be recorded in 30 minutes, 1 hour, 2-hour ,6-hour, 12 hour and 24 hours. Data analysis and interpretation will be done.

4.EXPECTED OUTCOMES:

Outcomes of this study may help in selection of optimal therapy with minimal safety issues by removing ambiguity, and reduce time and resource lost in decision making. The results may also help in formulation of Institutional standard treatment guidelines.