Effects of an Early Intensive Blood Pressure–lowering Strategy Using Remifentanil and Dexmedetomidine in Patients with Spontaneous Intracerebral Hemorrhage: A Multicenter, Prospective, Superiority, Randomized Controlled Trial

Author:

Dong Rui1,Li Fen2,Li Bin3,Chen Qiming4,Huang Xianjian5,Zhang Jiehua6,Huang Qibing7,Zhang Zeli8,Cao Yunxing9,Yang Mingbiao10,Li Jianwei11,Li Zhanfu12,Li Cuiyu13,Liu Guohua14,Zhong Shu15,Feng Guang16,Zhang Ming17,Xiao Yumei18,Lin Kangyue19,Shen Yunlong20,Shao Huanzhang21,Shi Yuan22,Yu Xiangyou23,Li Xiaopeng24,Yao Lan25,Du Xinyu26,Xu Ying27,Kang Pei28,Gao Guoyi29,Ouyang Bin30,Chen Wenjin31,Zeng Zhenhua32,Chen Pingyan33,Chen Chunbo34,Yang Hong35ORCID

Affiliation:

1. 1Department of Critical Care Medicine, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.

2. 2Department of Critical Care Medicine, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.

3. 3Department of Intensive Care Unit, The First Hospital of Lanzhou University, Lanzhou, China.

4. 4Department of Intensive Care Unit, The First Hospital of Lanzhou University, Lanzhou, China.

5. 5Department of Neurosurgery, Shenzhen Key Laboratory of Neurosurgery, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People’s Hospital, Shenzhen, China.

6. 6Department of Neurosurgery, Shenzhen Key Laboratory of Neurosurgery, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People’s Hospital, Shenzhen, China.

7. 7Department of Emergency Neurosurgical Intensive Care Unit, Qilu Hospital of Shandong University and Brain Science Research Institute of Shandong University, Jinan, China.

8. 8Department of Emergency Neurosurgical Intensive Care Unit, Qilu Hospital of Shandong University and Brain Science Research Institute of Shandong University, Jinan, China.

9. 9Department of Intensive Care Unit, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.

10. 10Neurosurgery Department, The First Affiliated Hospital of Hunan University of Medicine, Huaihua, China.

11. 11Department of Critical Care Medicine, Zhongshan People’s Hospital, Zhongshan, China.

12. 12Department of Intensive Care Unit, Guangdong Sanjiu Brain Hospital, Guangzhou, China.

13. 13Department of Intensive Care Unit, Guangdong Sanjiu Brain Hospital, Guangzhou, China.

14. 14Department of Neurosurgery, The Fifth Affiliated Hospital of Southern Medical University, Guangzhou, China.

15. 15Department of Neurosurgery, Guangxi Hospital Division of the First Affiliated Hospital, Sun Yat-sen University, Nanning, China.

16. 16Department of Neurosurgery, Henan Provincial People’s Hospital, People’s Hospital of Zhengzhou University, Zhengzhou, China.

17. 17Department of Neurosurgery, Henan Provincial People’s Hospital, People’s Hospital of Zhengzhou University, Zhengzhou, China.

18. 18Neurological Intensive Medicine Department, Maoming People’s Hospital, Maoming, China.

19. 19Neurological Intensive Medicine Department, Maoming People’s Hospital, Maoming, China.

20. 20Department of Neurosurgery, The Fifth Affiliated Hospital of Southern Medical University, Guangzhou, China.

21. 21Department of Critical Care Medicine, Henan Provincial People’s Hospital, People’s Hospital of Zhengzhou University, Zhengzhou, China.

22. 22Department of Critical Care Medicine, Henan Provincial People’s Hospital, People’s Hospital of Zhengzhou University, Zhengzhou, China.

23. 23Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.

24. 24Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.

25. 25Department of Emergency Medicine, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.

26. 26Department of Emergency Medicine, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.

27. 27Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.

28. 28Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.

29. 29Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

30. 30Department of Critical Care Medicine, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.

31. 31Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.

32. 32Department of Critical Care Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, China.

33. 33Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.

34. 34Department of Critical Care Medicine, Shenzhen People’s Hospital, The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology, Shenzhen, China.

35. 35Department of Critical Care Medicine, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.

Abstract

Background Although it has been established that elevated blood pressure and its variability worsen outcomes in spontaneous intracerebral hemorrhage, antihypertensives use during the acute phase still lacks robust evidence. A blood pressure–lowering regimen using remifentanil and dexmedetomidine might be a reasonable therapeutic option given their analgesic and antisympathetic effects. The objective of this superiority trial was to validate the efficacy and safety of this blood pressure–lowering strategy that uses remifentanil and dexmedetomidine in patients with acute intracerebral hemorrhage. Methods In this multicenter, prospective, single-blinded, superiority randomized controlled trial, patients with intracerebral hemorrhage and systolic blood pressure (SBP) 150 mmHg or greater were randomly allocated to the intervention group (a preset protocol with a standard guideline management using remifentanil and dexmedetomidine) or the control group (standard guideline-based management) to receive blood pressure–lowering treatment. The primary outcome was the SBP control rate (less than 140 mmHg) at 1 h posttreatment initiation. Secondary outcomes included blood pressure variability, neurologic function, and clinical outcomes. Results A total of 338 patients were allocated to the intervention (n = 167) or control group (n = 171). The SBP control rate at 1 h posttreatment initiation in the intervention group was higher than that in controls (101 of 161, 62.7% vs. 66 of 166, 39.8%; difference, 23.2%; 95% CI, 12.4 to 34.1%; P < 0.001). Analysis of secondary outcomes indicated that patients in the intervention group could effectively reduce agitation while achieving lighter sedation, but no improvement in clinical outcomes was observed. Regarding safety, the incidence of bradycardia and respiratory depression was higher in the intervention group. Conclusions Among intracerebral hemorrhage patients with a SBP 150 mmHg or greater, a preset protocol using a remifentanil and dexmedetomidine–based standard guideline management significantly increased the SBP control rate at 1 h posttreatment compared with the standard guideline-based management. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Publisher

Ovid Technologies (Wolters Kluwer Health)

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