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

Summary

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.

Conditions

• Early Systolic Blood Pressure Control Rate
• Hematoma Growth
• Blood Pressure Variability
• Healthcare Worker Satisfaction
• Duration 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Second Affiliated Hospital of Third Military Medical University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• The Second Hospital University of South China

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Department of Biostatistics, Southern Medical University

  collaborator UNKNOWN

• LanZhou University

  collaborator OTHER

• The First Affiliated Hospital of HuNan University of Medicine

  collaborator UNKNOWN

• Guangdong 999 Brain Hospital

  collaborator OTHER

• Maoming People's Hospital

  collaborator OTHER

• The Fifth Affiliated Hospital of Southern Medical University

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Hong Yang

  lead OTHER_GOV

Principal Investigators

• Wen-Jin Chen · Xuanwu Hospital, Beijing

• Hong Yang, Dr · The Third Affiliated Hospital of Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-06

Primary Completion

2021-02-14

Completion

2021-05-15

Countries

• China

Study Locations