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

NCT07364201 | Completed

• 2 other identifiers: SACUSU20251276/KEPK/USU/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hemorrhagic Strokes; Hemodynamic Instability; Postoperative Hypertension

Keywords

Hemorrhagic Stroke; Craniotomy; Nicardipine; Labetalol; Hemodynamic Control; Intensive Care Unit; Postoperative Hypertension; Blood Pressure Management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to Achieve Target Systolic Blood Pressure

  Within the first 24 hours postoperatively

Study Arms (2)

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.

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.

Drug: Labetalol

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.

Nicardipine

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.

Labetalol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Adam Malik Hospital, Haji Hospital Medan

Medan, North Sumatera, 20146, Indonesia

Location

MeSH Terms

Conditions

Hemorrhagic Stroke

Interventions

Nicardipine; Labetalol

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional parties are masked beyond the participant, care provider, investigator, and outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: November 14, 2025
• Primary Completion: January 3, 2026
• Study Completion: January 5, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ID (1)