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

Sponsor
The Third Affiliated Hospital of Southern Medical University
Study ID
NCT07695220
Status
Not Yet Recruiting

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Conditions

  • Intracerebral Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remifentanil and Dexmedetomidine — DRUG
    Participants 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 — DRUG
    Participants 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.

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guideline-based standard care using remifentanil and dexmedetomidine
    Based on the standard blood pressure treatment protocol from the 2022 American Heart Association/American Stroke Association "Guidelines for the Management of Spontaneous Intracerebral Hemorrhage," the administration of remifentanil and dexmedetomidine will be initiated within 1 hour after randomization. The treatment will be continued for 7 days, or until the patient is transferred out of the intensive care unit if this occurs before day 7.
  • Active Comparator: Guideline-based standard care
    Management will follow the 2022 American Heart Association/American Stroke Association "Guidelines for the Management of Patients with Spontaneous Intracerebral Hemorrhage".

Primary Outcome Measure

The modified Rankin Scale score at 90 days post-treatment [ Time Frame: 90 days post-treatment ]

Central Contacts

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