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| ID | Type | Description | Link |
|---|---|---|---|
| 1276/KEPK/USU/2025 | Other Identifier | Ethics Committee Approval For Conducting Health Research Universitas Sumatera Utara |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicardipine | Experimental | Participants assigned to this arm receive intravenous nicardipine for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke. |
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| Labetalol | Experimental | Participants assigned to this arm receive intravenous labetalol for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Hemodynamic Control | 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. | First 24 hours postoperatively in the intensive care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Target Systolic Blood Pressure | Time required to reach the target systolic blood pressure range (140-150 mmHg) after initiation of the study drug. | Within the first 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adam Malik Hospital, Haji Hospital Medan | Medan | North Sumatera | 20146 | Indonesia |
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Participants are randomly assigned in parallel to one of two intervention groups to receive either intravenous nicardipine or intravenous labetalol during postoperative intensive care unit management. Each participant receives only one study intervention, and outcomes are compared between groups.
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No additional parties are masked beyond the participant, care provider, investigator, and outcomes assessor.
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| 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. |
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009529 | Nicardipine |
| D007741 | Labetalol |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
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