A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke Brain Surgery

Sponsor
Universitas Sumatera Utara
Study ID
NCT07364201
Status
Completed

Conditions

  • Hemodynamic Instability
  • Hemorrhagic Strokes
  • Postoperative Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nicardipine — DRUG
    Intravenous nicardipine is administered as a continuous infusion for postoperative blood pressure control in patients admitted to the intensive care unit after craniotomy for hemorrhagic stroke. The infusion is titrated according to a standardized protocol to achieve and maintain the target systolic blood pressure range during the first 24 hours of postoperative care.
  • Labetalol — DRUG
    Intravenous labetalol is administered as a continuous infusion for postoperative blood pressure control in patients admitted to the intensive care unit after craniotomy for hemorrhagic stroke. The infusion is titrated according to a standardized protocol to achieve and maintain the target systolic blood pressure range during the first 24 hours of postoperative care.

Study Details

Patients with hemorrhagic stroke who undergo brain surgery (craniotomy) often experience high blood pressure after surgery. Poor blood pressure control can increase the risk of bleeding, brain injury, and other serious complications. In the intensive care unit (ICU), intravenous blood pressure medications are commonly used to keep blood pressure within a safe range. This study aims to compare two commonly used intravenous blood pressure medications, nicardipine and labetalol, in patients who have undergone craniotomy for hemorrhagic stroke. The study will evaluate how well each medication controls blood pressure and heart rate during the first 24 hours of ICU care, as well as the speed at which the target blood pressure is achieved and the occurrence of side effects. Participants will receive either nicardipine or labetalol according to the study protocol. Blood pressure and heart rate will be continuously monitored in the ICU as part of standard care. The results of this study are expected to help health care providers choose the most appropriate medication to achieve stable blood pressure control and improve postoperative care for patients with hemorrhagic stroke.

Key Dates

Start date
Nov 14, 2025
Status verified
Jan 2026
Primary completion
Jan 3, 2026
Completion
Jan 5, 2026

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nicardipine
    Participants assigned to this arm receive intravenous nicardipine for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke.
  • Experimental: Labetalol
    Participants assigned to this arm receive intravenous labetalol for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke.

Primary Outcome Measure

Effectiveness of Hemodynamic Control [ Time Frame: First 24 hours postoperatively in the intensive care unit ]

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