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Randomized Controlled Trial Multicenter Study
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.
- Rui Dong, Fen Li, Bin Li, Qiming Chen, Xianjian Huang, Jiehua Zhang, Qibing Huang, Zeli Zhang, Yunxing Cao, Mingbiao Yang, Jianwei Li, Zhanfu Li, Cuiyu Li, Guohua Liu, Shu Zhong, Guang Feng, Ming Zhang, Yumei Xiao, Kangyue Lin, Yunlong Shen, Huanzhang Shao, Yuan Shi, Xiangyou Yu, Xiaopeng Li, Lan Yao, Xinyu Du, Ying Xu, Pei Kang, Guoyi Gao, Bin Ouyang, Wenjin Chen, Zhenhua Zeng, Pingyan Chen, Chunbo Chen, and Hong Yang.
- Department of Critical Care Medicine, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
- Anesthesiology. 2024 Jul 1; 141 (1): 100115100-115.
BackgroundAlthough 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.MethodsIn 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.ResultsA 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.ConclusionsAmong 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.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc., on behalf of the American Society of Anesthesiologists.
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