Clinical trial

Clinical Study of the Safety and Efficacy of Analgesia-first Minimal Sedation as an Early Antihypertensive Treatment for Spontaneous Intracerebral Hemorrhage

NCT03207100

Name

201704004

Description

This study evaluates safety and efficacy of analgesia-first minimal sedation as an early antihypertensive treatment for spontaneous intracerebral hemorrhage. The analgesia-first minimal sedation strategy relies on the remifentanil-mediated alleviation of pain-induced stress response and the antisympathetic activity of dexmedetomidine to restore the elevated blood pressure to normal level in patients with spontaneous intracerebral hemorrhage. This strategy allows rapid stabilization of blood pressure, and its use as a pre-treatment for patients on mechanical ventilation prior to painful procedures reduces blood pressure variability and thereby results in etiologic treatment. It is more effective in blood pressure control than conventional symptomatic antihypertensive treatment, reduces the incidence of early hematoma expansion and improves prognosis, ,lowers healthcare workers workload, increases patient adherence, and improves healthcare worker satisfaction.

Trial arms

Trial start

2017-12-06

Estimated PCD

2021-02-14

Trial end

2021-05-15

Status

Completed

Treatment

Analgesia-first minimal sedation

Remifentanil will be administered by IV infusion and maintained at a dose of 0.025 μg/kg/min in non-mechanically ventilated patients and a dose of 0.05 μg/kg/min in mechanically ventilated patients. BP will be measured after 10 min of continuous infusion.If systolic BP is still ≥ 140 mmHg, then dexmedetomidine will be applied using an infusion pump at a dose of 0.2 μg/kg/h. BP will be measured again after 15 min of continuous infusion of dexmedetomidine. If systolic BP is still ≥ 140 mmHg, the dose of dexmedetomidine can be increased 0.1 μg/kg/h to the maximum of 0.6 μg/kg/h.If the maximum dose of dexmedetomidine does not lower blood pressure, use routine blood pressure reduction programs in each center to reduce blood pressure to the target range. Mechanically ventilated patients will be given a rapid remifentanil (0.5 μg/kg) infusion to reduce procedure-related pain.

Arms:

Analgesia-first minimal sedation group

Antihypertensive treatment

Routine antihypertensive treatment will be performed in accordance with the protocol of each respective research center. Urapidil, nicardipine, and labetalol will be used in this group. Urapidil will be used as follows: a slow IV injection of 10-15 mg and then IV pumping for maintenance at an initial rate of 2 mg/min, adjusted according to BP to a maximum of 9 mg/min. Nicardipine will be used as follows: IV pumping at 0.5μg/kg/min adjusted according to BP to a maximum of 6μg/kg/min. Labetalol will be used as follows: IV infusion for maintenance at 1-4 mg/min until the aim is reached.The mechanically ventilated patients in the control group will be administered a rapid physiological saline infusion as a controlled pretreatment.

Arms:

Antihypertensive drug treatment group

Size

338

Primary endpoint

Systolic BP control rate at 1h post-treatment initiation

1h post-treatment initiation

Eligibility criteria

Inclusion Criteria: 1. Definitive diagnosis of ICH-induced acute brain injury by CT; 2. Systolic BP ≥150 mmHg for at least twice; 3. \>18 years old; 4. Feasible for emergency antihypertensive treatment and real-time BP monitoring; 5. Disease onset is within 24h; 6. ICU or stroke unit admission within 24h. Exclusion Criteria: 1. Subject has contraindications for emergency intensified antihypertensive treatment; 2. Intracranial hemorrhage secondary to intracranial tumor, recent trauma, cerebral infarction and thrombolytic therapy; 3. History of ischemic stroke within 30 days before disease onset; 4. Clinical or imaging examination reveals an expected high mortality in subject within the next 24h; 5. Presence of dementia or significant post-stroke disability; 6. Coagulation disorder caused by drugs or hematologic diseases; 7. Allergy to opioids; 8. Interference test result, assessment and follow-up of comorbidity; 9. Presence of sinus arrest, borderline rhythm, grade II and above atrioventricular block and malignant arrhythmia; 10. Individual is pregnant or lactating; 11. Currently participating in other drug studies or clinical trials; 12. Subject or guardian is unwilling to provide his/her informed consent form, or subject is highly unable to persist with the study and follow-up; 13. Subject's participation in the study will increase his/her study-related risk, and other reasons that make the subject unsuitable for the study as determined by the investigator.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects are grouped into the analgesia-first minimal sedation group (experimental group) or antihypertensive drug treatment group (control group) using the central randomization system upon enrollment. Antihypertensive intervention is performed on the subjects in accordance to the protocol of each group.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'This study uses a single-blinded design in which only the investigators and not the subjects know the method of intervention.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 338, 'type': 'ACTUAL'}}

Updated at

2023-12-07

1 organization

2 products

5 indications

Organization

Hong Yang

Product

Analgesia-first minimal sedation

Indication

Early Systolic Blood Pressure Control Rate

Indication