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.

IF 9.1 1区 医学 Q1 ANESTHESIOLOGY Anesthesiology Pub Date : 2024-07-01 DOI:10.1097/ALN.0000000000004986
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, Hong Yang
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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:

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使用瑞芬太尼和右美托咪定的早期强化降压策略对自发性脑出血患者的影响:一项多中心、前瞻性、优越性随机对照试验。
背景:尽管已经证实血压升高及其变化会恶化自发性脑出血的预后,但在急性期使用降压药仍缺乏有力的证据。鉴于瑞芬太尼和右美托咪定具有镇痛和抗交感神经作用,使用瑞芬太尼和右美托咪定的降压方案可能是一种合理的治疗选择。这项优越性试验的目的是验证在急性脑出血患者中使用瑞芬太尼和右美托咪定这种降压策略的有效性和安全性:在这项多中心、前瞻性、单盲、优势随机对照试验中,收缩压(SBP)≥150 mmHg的脑出血患者被随机分配到干预组(使用瑞芬太尼和右美托咪定的标准指南管理预设方案)或对照组(基于标准指南的管理)接受降压治疗。主要结果是 SBP 控制率(结果:共有 338 名患者被分配到干预组(167 人)或对照组(171 人)。干预组在治疗开始后 1 小时的 SBP 控制率高于对照组(101/161,62.7% vs. 66/166,39.8%,差异 23.2%,95% CI,12.4 至 34.1%,P <0.001)。次要结果分析表明,干预组患者能有效减少躁动,同时获得较轻的镇静效果,但临床结果未见改善。在安全性方面,干预组心动过缓和呼吸抑制的发生率较高:结论:在SBP≥150 mmHg的脑出血患者中,使用基于瑞芬太尼和右美托咪定的标准指南管理的预设方案与标准指南管理相比,能显著提高治疗后1 h的SBP控制率。(ClinicalTrials.gov编号:NCT03207100,注册日期:2017年6月30日)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Anesthesiology
Anesthesiology 医学-麻醉学
CiteScore
10.40
自引率
5.70%
发文量
542
审稿时长
3-6 weeks
期刊介绍: With its establishment in 1940, Anesthesiology has emerged as a prominent leader in the field of anesthesiology, encompassing perioperative, critical care, and pain medicine. As the esteemed journal of the American Society of Anesthesiologists, Anesthesiology operates independently with full editorial freedom. Its distinguished Editorial Board, comprising renowned professionals from across the globe, drives the advancement of the specialty by presenting innovative research through immediate open access to select articles and granting free access to all published articles after a six-month period. Furthermore, Anesthesiology actively promotes groundbreaking studies through an influential press release program. The journal's unwavering commitment lies in the dissemination of exemplary work that enhances clinical practice and revolutionizes the practice of medicine within our discipline.
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