Analgesia-first Minimal Sedation for Spontaneous Intracerebral Hemorrhage Early Antihypertensive Treatment
NCT ID: NCT03207100
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
338 participants
INTERVENTIONAL
2017-12-06
2021-05-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Analgesia-first minimal sedation group
Using analgesia-first minimal sedation strategy to implement antihypertensive therapy.
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.
Antihypertensive drug treatment group
Using routine antihypertensive drugs to implement antihypertensive therapy.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Qilu Hospital of Shandong University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Second Affiliated Hospital of Third Military Medical University
OTHER
Henan Provincial People's Hospital
OTHER
The Second Hospital University of South China
OTHER
Shenzhen Second People's Hospital
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
Department of Biostatistics, Southern Medical University
UNKNOWN
LanZhou University
OTHER
The First Affiliated Hospital of HuNan University of Medicine
UNKNOWN
Guangdong 999 Brain Hospital
OTHER
Maoming People's Hospital
OTHER
The Fifth Affiliated Hospital of Southern Medical University
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Hong Yang
OTHER_GOV
Responsible Party
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Hong Yang
Doctor of Medicine (M.D.);Associate Senior Doctor
Principal Investigators
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Wen-Jin Chen
Role: STUDY_CHAIR
Xuanwu Hospital, Beijing
Hong Yang, Dr
Role: STUDY_CHAIR
The Third Affiliated Hospital of Southern Medical University
Locations
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong 999 Brain Hospital
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
MaoMing People's Hospital
Maoming, Guangdong, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital Sun-yet sen University
Zhuhai, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Second Hospital University of South China
Hengyang, Hunan, China
The First Affiliated Hospital of HuNan University of Medicine
Huaihua, Hunan, China
Qilu Hospital of Shandong University
Qingdao, Shandong, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kuming Medical University
Kunming, Yunnan, China
Countries
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References
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Other Identifiers
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201704004
Identifier Type: -
Identifier Source: org_study_id