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

NCT07695220 | Not Yet Recruiting DMC

• 1 other identifier: 2026SMU017
• Study Type: interventional
• Target: 1,116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhage; Remifentanil; Dexmedetomidine; Blood pressure-lowering

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days post-treatment

Secondary Outcomes (10)

• Poor Functional Outcome

  90 days post-treatment

• Blood Pressure Management

  24 hours, 3 days, and 7 days post-treatment

• Glycemic Control

  24 hours, 3 days, and 7 days post-treatment

• National Institutes of Health Stroke Scale

  7 days

• Glasgow Coma Scale

  7 days

Study Arms (2)

Guideline-based standard care using remifentanil and dexmedetomidine

EXPERIMENTAL

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.

Drug: Remifentanil and Dexmedetomidine

Guideline-based standard care

ACTIVE COMPARATOR

Management will follow the 2022 American Heart Association/American Stroke Association "Guidelines for the Management of Patients with Spontaneous Intracerebral Hemorrhage".

Drug: Guideline standard care

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-based standard care using remifentanil and dexmedetomidine

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.

Guideline-based standard care

Eligibility Criteria

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

You may qualify if:

• 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.
• Admission to a monitored unit capable of active acute care (e.g., acute stroke unit, emergency department, or intensive care unit).
• Written informed consent provided by the patient or legally authorized representative.

You may not qualify if:

• 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.
• Known advanced dementia or pre-stroke disability (pre- modified Rankin Scale score ≥ 3).
• Coagulopathy due to medication or hematologic disorder.
• Comorbid conditions that would interfere with outcome assessment or follow-up (e.g., active malignancy, end-stage organ failure).
• Known hypersensitivity to remifentanil or dexmedetomidine.
• Pregnancy or lactation.
• Concurrent participation in another investigational drug or device trial.
• Patient or legally authorized representative unwilling or unable to provide informed consent, or judged unlikely to comply with study procedures or follow-up.

Sponsors & Collaborators

• Shenzhen People's Hospital: collaborator
• The Third Affiliated Hospital of Southern Medical University: lead

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• Steiner T, Purrucker JC, Aguiar de Sousa D, Apostolaki-Hansson T, Beck J, Christensen H, Cordonnier C, Downer MB, Eilertsen H, Gartly R, Gerner ST, Ho L, Holt Jahr S, Klijn CJ, Martinez-Majander N, Orav K, Petersson J, Raabe A, Sandset EC, Schreuder FH, Seiffge D, Al-Shahi Salman R. European Stroke Organisation (ESO) and European Association of Neurosurgical Societies (EANS) guideline on stroke due to spontaneous intracerebral haemorrhage. Eur Stroke J. 2025 Dec;10(4):1007-1086. doi: 10.1177/23969873251340815. Epub 2025 May 22.

  PMID: 40401775 BACKGROUND

• Qureshi AI, Qureshi MH. Acute hypertensive response in patients with intracerebral hemorrhage pathophysiology and treatment. J Cereb Blood Flow Metab. 2018 Sep;38(9):1551-1563. doi: 10.1177/0271678X17725431. Epub 2017 Aug 16.

  PMID: 28812942 BACKGROUND

• Sheth KN. Spontaneous Intracerebral Hemorrhage. N Engl J Med. 2022 Oct 27;387(17):1589-1596. doi: 10.1056/NEJMra2201449. No abstract available.

  PMID: 36300975 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Remifentanil; Dexmedetomidine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• Hong Yang, MD

  The Third Affiliated Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Dong, MM

CONTACT

+86 -15622176026; dongrui_0419@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 10, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: It is expected to be made available in June 2029 and will remain accessible for a period of 5 years.
• Access Criteria: Contacte to principal investigator.