Nicardipine vs. Labetalol

Sponsor
Haseki Training and Research Hospital
Study ID
NCT07277283
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nicardipine intravenous — DRUG
    In the nicardipine group, an 18-gauge peripheral IV catheter was preferably placed in the antecubital fossa. Continuous infusion was initiated at a starting dose of 5 mg/hour and titrated upward by 1 mg/hour every 5 minutes according to the BP response. Administration was performed using an electronic infusion pump.
  • labetalol intravenous — DRUG
    In the labetalol group, an 18-gauge peripheral IV catheter was preferably placed in the antecubital fossa. An initial 20 mg dose of labetalol was administered as an IV bolus. If needed, additional 20 mg boluses were given every 5 minutes, not exceeding a cumulative dose of 300 mg.

Study Details

In this ED-based study, the investigators compared the time to reach target blood pressure (BP) between hypertensive patients with acute ischemic stroke (AIS) undergoing intravenous (IV) thrombolysis and/or mechanical thrombectomy who received IV nicardipine versus labetalol. Additionally, the investigators evaluated the rate of early neurological improvement (ENI), length of hospital stay (LOS), in-hospital mortality, and adverse event profiles between the two treatment groups.

Key Dates

Start date
Feb 1, 2025
Status verified
Dec 2025
Primary completion
Jul 1, 2025
Completion
Aug 1, 2025

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Nicardipine group
    The nicardipine group received an IV infusion of nicardipine.
  • Active Comparator: Labetalol group
    The labetalol group received an IV bolus of labetalol.

Primary Outcome Measure

Time to reach target blood pressure [ Time Frame: at 15 minutes after the drug administration ]

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