A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke Brain Surgery (NIC-LAB ICU)

January 15, 2026 updated by: Septani Anugrah Cinditya, Universitas Sumatera Utara

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • North Sumatera
      • Medan, North Sumatera, Indonesia, 20146
        • Adam Malik Hospital, Haji Hospital Medan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Nicardipine
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.
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.
Drug: Labetalol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 24 hours postoperatively in the intensive care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Achieve Target Systolic Blood Pressure
Time Frame: Within the first 24 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Actual)

January 3, 2026

Study Completion (Actual)

January 5, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SACUSU2025
  • 1276/KEPK/USU/2025 (Other Identifier: Ethics Committee Approval For Conducting Health Research Universitas Sumatera Utara)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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