Intracerebral hemorrhage (ICH) remains the most devastating subtype of stroke, with a case fatality rate of approximately 40% at one months post-onset, imposing a particularly heavy medical and economic burden on low- and middle-income countries. Studies have shown that poor prognosis in ICH patients is associated with acute blood pressure elevation and hematoma expansion after onset. Blood pressure control during the acute phase is considered a potentially key therapeutic strategy for improving outcomes in ICH patients; however, no clinical study has yet demonstrated a clear advantage of any specific antihypertensive agent or combination. Previous researchers have confirmed that the combined use of remifentanil and dexmedetomidine, while providing effective analgesia, sedation, and anti-sympathetic effects, could reduce dramatic fluctuations in blood pressure and heart rate, thereby facilitating more stable blood pressure reduction and potentially further improving functional outcomes in ICH patients. The investigators plan to conduct a multicenter, prospective, randomized controlled, superiority clinical trial within mainland China to evaluate the efficacy and safety of an early intensive blood pressure-lowering strategy using remifentanil combined with dexmedetomidine for improving functional prognosis in acute ICH patients. This study aims to provide evidence-based medical support for the use of remifentanil combined with dexmedetomidine in early intensive blood pressure-lowering in patients with ICH, to enrich the available options for early intensive blood pressure-lowering strategies, to improve the adverse prognosis of patients.
Age ≥ 18 years.
Acute intracerebral hemorrhage confirmed by non-contrast head computed tomography.
Symptom onset ≤ 6 h before randomization.
At least two systolic blood pressure ≥ 150 mmHg separated by > 2 min prior to randomization.
Contraindication to intensive blood-pressure lowering (e.g., severe stenosis of carotid, vertebral, or cerebral arteries; Moyamoya disease; Takayasu arteritis; critical aortic stenosis).
Clear evidence that the hemorrhage is secondary to a structural brain abnormality (arteriovenous malformation, aneurysm, tumor, trauma, infarct) or recent thrombolysis.
Ischemic stroke within the preceding 30 days.
Very high probability of death within 24 h based on clinical and/or radiologic criteria.
Parallel
Remifentanil and Dexmedetomidine
DrugParticipants will receive remifentanil and dexmedetomidine within 30 minutes after treatment initiation, and the treatment will be continued for 7 days or until discharge from the intensive care unit. The starting dose of remifentanil is 0.025 μg/kg/min, which will be adjusted during infusion based on the patient's blood pressure and analgesic requirements. For non-mechanically ventilated patients, the dose adjustment range is 0.025-0.05 μg/kg/min; for mechanically ventilated patients, the dose adjustment range is 0.025-0.15 μg/kg/min. The starting dose of dexmedetomidine is 0.2 μg/kg/h, which will be adjusted during infusion based on the patient's blood pressure and sedation requirements, with a dose adjustment range of 0.2-0.7 μg/kg/h.
Guideline standard care
DrugParticipants will receive conventional treatment in accordance with the "Guidelines for the Management of Spontaneous Intracerebral Hemorrhage" published by the American Heart Association and the American Stroke Association.
The modified Rankin Scale score at 90 days post-treatment
The modified Rankin Scale score at 90 days post-treatment will be analyzed as an ordinal outcome (scores 0-6). The modified Rankin Scale is a standardized global 7-level disability scale, where a score of 0 or 1 indicates a favorable outcome (no symptoms or no significant disability), scores 2-5 represent increasing levels of disability and dependency, and a score of 6 indicates death.
Poor Functional Outcome
A modified Rankin Scale score of 3-6 at 90 days is defined as a poor outcome, including death and severe disability. Death is defined as modified Rankin Scale 6, and severe disability is defined as modified Rankin Scale 3-5. Death and severe disability will be combined and reported as a composite poor outcome measure, and will also be analyzed separately.
Blood Pressure Management
(1) 1-hour blood pressure control rate: Defined as at least twice systolic blood pressure measurements \<140 mmHg within the first hour after treatment initiation. (2) Mean blood pressure values: The average blood pressure values within 24 hours, 3 days, and 7 days post-treatment will be calculated for each group using all available measurements. (3) Blood pressure variability: Coefficient of Variation and Average Real Variability will be calculated based on all blood pressure measurements obtained within 24 hours, 3 days, and 7 days post-treatment. (4) Use of antihypertensive agents: The need for antihypertensive medications within 24 hours, 3 days, and 7 days post-treatment will be recorded. Intravenous and oral/enteral medications will be documented separately, including the number of agents used if applicable.
Glycemic Control
(1) Mean blood glucose values: The average glucose values within 24 hours, 3 days, and 7 days post-treatment will be calculated for each group using all available measurements. (2) Hypoglycemia rate: Hypoglycemia is defined as a blood glucose level \<2.8 mmol/L in non-diabetic patients and \<4.0 mmol/L in diabetic patients. The actual glucose value at the time of hypoglycemia will also be recorded. (3) Insulin use: The need for insulin and the total insulin dosage within 24 hours, 3 days, and 7 days post-treatment will be documented.
National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale at 7 days will be evaluated. National Institute of Health Stroke Scale, range from 0 to 42, with higher scores indicating more severe neurological deficits.
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The Third Affiliated Hospital of Southern Medical University
Lead sponsor
Shenzhen People's Hospital
Collaborator
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