Hemorrhagic StrokesNIC-LAB ICUNCT07364201
A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke Brain Surgery
A study testing Nicardipine and Labetalol in people with Hemorrhagic Strokes and Postoperative Hypertension, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhagic Strokes, Postoperative Hypertension, Hemodynamic Instability
- What is being tested?
- Nicardipine and Labetalol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Nov 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Adam Malik Hospital, Haji Hospital Medan
Medan, North Sumatera, 20146
About this study
Official title: A Comparison of the Effectiveness of Nicardipine and Labetalol in Controlling Hemodynamics in Postoperative Hemorrhagic Stroke Craniotomy Patients in the Intensive Care Unit
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.
Read the detailed description
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.
- Being tested
- Nicardipine, Labetalol
- Keywords
- Hemorrhagic Stroke, Craniotomy, Nicardipine, Labetalol, Hemodynamic Control, Intensive Care Unit, Postoperative Hypertension, Blood Pressure Management
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
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.
LabetalolDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nicardipine |
| 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. Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours postoperatively in the intensive care unit
Secondary outcomes (1)
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.
Measured: Within the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start14 Nov 2025
- Primary completion3 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic StrokesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Septani Anugrah Cinditya, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364201
- Sponsor's protocol ID
- SACUSU2025
- Other IDs
- 1276/KEPK/USU/2025
- Acronym
- NIC-LAB ICU
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Nicardipine and Labetalol in Controlling Hemodynamics in Postoperative Hemorrhagic Stroke Craniotomy Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07364201
- Acronym / sponsor ID
- NIC-LAB ICU / SACUSU2025
- Keywords
- Hemorrhagic Stroke, Craniotomy, Nicardipine, Labetalol, Hemodynamic Control, Intensive Care Unit, Postoperative Hypertension, Blood Pressure Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nicardipine | Experimental | Drug: NicardipineParticipants assigned to this arm receive intravenous nicardipine for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke. |
| Labetalol | Experimental | Drug: LabetalolParticipants assigned to this arm receive intravenous labetalol for postoperative blood pressure control during intensive care unit management following craniotomy for hemorrhagic stroke. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicardipineIntravenous 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. | Drug | Nicardipine |
| LabetalolIntravenous 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. | Drug | Labetalol |
Primary outcome
Effectiveness of Hemodynamic Control
Time frame: 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.
1 secondary outcome
Time to Achieve Target Systolic Blood Pressure
Time frame: Within the first 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicardipine and Labetalol in people with Hemorrhagic Strokes and Postoperative Hypertension, run by Universitas Sumatera Utara at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Hemodynamic Control (time frame: First 24 hours postoperatively in the intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.