A Comparison of the Effectiveness of Nicardipine and Labetalol in Controlling Hemodynamics in Postoperative Hemorrhagic Stroke Craniotomy Patients in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effectiveness of Hemodynamic Control
研究概览
简要总结
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.
详细描述
Hemorrhagic stroke patients undergoing craniotomy are at increased risk of postoperative blood pressure elevation and hemodynamic instability, which may contribute to secondary brain injury, intracranial bleeding, and other postoperative complications. Appropriate blood pressure management in the intensive care unit (ICU) is therefore a critical component of postoperative care in this population.
Nicardipine and labetalol are intravenous antihypertensive agents commonly used for blood pressure control in neurocritical care settings. Both medications are recommended in current clinical practice; however, their hemodynamic profiles, including onset of action, stability of blood pressure control, and adverse effect patterns, differ. Evidence directly comparing these agents in the postoperative period following craniotomy for hemorrhagic stroke remains limited.
This study is a double-blind randomized clinical trial conducted in adult patients admitted to the ICU after craniotomy for hemorrhagic stroke. Eligible participants are randomly assigned to receive either intravenous nicardipine or intravenous labetalol according to a standardized treatment protocol. Hemodynamic monitoring, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, is performed continuously using an arterial catheter as part of routine ICU management.
The primary objective of the study is to compare the effectiveness of nicardipine and labetalol in achieving and maintaining target systolic blood pressure during the first 24 hours of postoperative ICU care. Secondary objectives include comparison of time to reach target blood pressure, blood pressure variability, and the incidence of predefined adverse events such as bradycardia, hypotension, and tachycardia.
The findings of this study are expected to provide clinically relevant information regarding the comparative performance of nicardipine and labetalol for postoperative hemodynamic control in patients with hemorrhagic stroke, and to inform evidence-based blood pressure management strategies in neurocritical care practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No additional parties are masked beyond the participant, care provider, investigator, and outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years old).
- •Diagnosed with hemorrhagic stroke.
- •Undergoing craniotomy for hemorrhagic stroke.
- •Admitted to the intensive care unit after surgery.
- •Require intravenous antihypertensive therapy for postoperative blood pressure control.
- •Invasive arterial blood pressure monitoring in place.
- •Written informed consent obtained from the patient or legally authorized representative.
排除标准
- •Known hypersensitivity or contraindication to nicardipine or labetalol.
- •Severe bradycardia, advanced atrioventricular block, or uncontrolled heart failure.
- •History of bronchial asthma or severe chronic obstructive pulmonary disease.
- •Hemodynamic instability requiring vasopressor support at enrollment.
- •Pregnancy or breastfeeding.
- •Participation in another interventional clinical study during the study period.
研究组 & 干预措施
Nicardipine
Participants assigned to this arm receive intravenous nicardipine for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke.
干预措施: Nicardipine (Drug)
Labetalol
Participants assigned to this arm receive intravenous labetalol for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke.
干预措施: Labetalol (Drug)
结局指标
主要结局
Effectiveness of Hemodynamic Control
时间窗: First 24 hours postoperatively in the intensive care unit
Comparison of systolic blood pressure (SBP) control between the nicardipine and labetalol groups during the first 24 hours after craniotomy for hemorrhagic stroke, assessed using continuous invasive arterial blood pressure monitoring.
次要结局
- Time to Achieve Target Systolic Blood Pressure(Within the first 24 hours postoperatively)
研究者
Septani Anugrah Cinditya
Principal Investigator
Universitas Sumatera Utara