REmifentanil And Dexmedetomidine for EarlY Intensive Blood Pressure Lowering in ICH.

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.

Inclusion Criteria: 1. Age ≥ 18 years. 2. Acute intracerebral hemorrhage confirmed by non-contrast head computed tomography. 3. Symptom onset ≤ 6 h before randomization. 4. At least two systolic blood pressure ≥ 150 mmHg separated by \> 2 min prior to randomization. 5. Admission to a monitored unit capable of active acute care (e.g., acute stroke unit, emergency department, or intensive care unit). 6. Written informed consent provided by the patient or legally authorized representative. Exclusion Criteria: 1. Contraindication to intensive blood-pressure lowering (e.g., severe stenosis of carotid, vertebral, or cerebral arteries; Moyamoya disease; Takayasu arteritis; critical aortic stenosis). 2. Clear evidence that the hemorrhage is secondary to a structural brain abnormality (arteriovenous malformation, aneurysm, tumor, trauma, infarct) or recent thrombolysis. 3. Ischemic stroke within the preceding 30 days. 4. Very high probability of death within 24 h based on clinical and/or radiologic criteria. 5. Known advanced dementia or pre-stroke disability (pre- modified Rankin Scale score ≥ 3). 6. Coagulopathy due to medication or hematologic disorder. 7. Comorbid conditions that would interfere with outcome assessment or follow-up (e.g., active malignancy, end-stage organ failure). 8. Known hypersensitivity to remifentanil or dexmedetomidine. 9. Pregnancy or lactation. 10. Concurrent participation in another investigational drug or device trial. 11. Patient or legally authorized representative unwilling or unable to provide informed consent, or judged unlikely to comply with study procedures or follow-up.