Analgesia-first Minimal Sedation for Spontaneous Intracerebral Hemorrhage Early Antihypertensive Treatment

NACompletedINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

December 6, 2017

Primary Completion Date

February 14, 2021

Study Completion Date

May 15, 2021

Conditions
Early Systolic Blood Pressure Control RateHematoma GrowthBlood Pressure VariabilityHealthcare Worker SatisfactionDuration of ICU Treatment and Mechanical Ventilation
Interventions
COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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.

Trial Locations (17)

100053

Xuanwu Hospital Capital Medical University, Beijing

266035

Qilu Hospital of Shandong University, Qingdao

400037

Xinqiao Hospital of Army Medical University, Chongqing

418000

The First Affiliated Hospital of HuNan University of Medicine, Huaihua

421001

The Second Hospital University of South China, Hengyang

450003

Henan Provincial People's Hospital, Zhengzhou

510000

Guangdong 999 Brain Hospital, Guangzhou

510630

The Third Affiliated Hospital of Southern Medical University, Guangzhou

510900

The Fifth Affiliated Hospital of Southern Medical University, Guangzhou

518035

The Second People's Hospital of Shenzhen, Shenzhen

519000

The Fifth Affiliated Hospital Sun-yet sen University, Zhuhai

525000

MaoMing People's Hospital, Maoming

528400

Zhongshan People's Hospital, Zhongshan

530021

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

650032

The First Affiliated Hospital of Kuming Medical University, Kunming

730000

The First Hospital of Lanzhou University, Lanzhou

830054

The First Affiliated Hospital of Xinjiang Medical University, Ürümqi

All Listed Sponsors
collaborator

Xuanwu Hospital, Beijing

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

collaborator

Second Affiliated Hospital of Third Military Medical University

OTHER

collaborator

Henan Provincial People's Hospital

OTHER

collaborator

The Second Hospital University of South China

OTHER

collaborator

Shenzhen Second People's Hospital

OTHER

collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

collaborator

Department of Biostatistics, Southern Medical University

UNKNOWN

collaborator

LanZhou University

OTHER

collaborator

The First Affiliated Hospital of HuNan University of Medicine

UNKNOWN

collaborator

Guangdong 999 Brain Hospital

OTHER

collaborator

Maoming People's Hospital

OTHER

collaborator

The Fifth Affiliated Hospital of Southern Medical University

OTHER

collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

lead

Hong Yang

OTHER_GOV

NCT03207100 - Analgesia-first Minimal Sedation for Spontaneous Intracerebral Hemorrhage Early Antihypertensive Treatment | Biotech Hunter | Biotech Hunter