Remifentanil vs. dexmedetomidine for cardiac surgery patients with noninvasive ventilation intolerance: a multicenter randomized controlled trial.

Autor: Hao GW; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Wu JQ; Department of Nursing, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Yu SJ; Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Liu K; Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Xue Y; Department of Nursing, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Gong Q; Department of Cardiovascular Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, Anhui, China., Xie RC; Department of Critical Care Medicine, Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen, 361015, Fujian, China., Ma GG; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Su Y; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Hou JY; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Zhang YJ; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Liu WJ; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China., Li W; Department of Intensive Care Unit, The People's Hospital of Fujian Traditional Medical University, Fuzhou, 350004, Fujian, China. sicu.lw@163.com., Tu GW; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. tu.guowei@zs-hospital.sh.cn., Luo Z; Department of Cardiac Intensive Care Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. luo.zhe@zs-hospital.sh.cn.; Department of Critical Care Medicine, Shanghai Xuhui Central Hospital, Zhongshan Xuhui Hospital, Fudan University, Shanghai, 200020, China. luo.zhe@zs-hospital.sh.cn.; Shanghai Key Lab of Pulmonary Inflammation and Injury, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. luo.zhe@zs-hospital.sh.cn.
Jazyk: angličtina
Zdroj: Journal of intensive care [J Intensive Care] 2024 Sep 18; Vol. 12 (1), pp. 35. Date of Electronic Publication: 2024 Sep 18.
DOI: 10.1186/s40560-024-00750-2
Abstrakt: Background: The optimal sedative regime for noninvasive ventilation (NIV) intolerance remains uncertain. The present study aimed to assess the efficacy and safety of remifentanil (REM) compared to dexmedetomidine (DEX) in cardiac surgery patients with moderate-to-severe intolerance to NIV.
Methods: In this multicenter, prospective, single-blind, randomized controlled study, adult cardiac surgery patients with moderate-to-severe intolerance to NIV were enrolled and randomly assigned to be treated with either REM or DEX for sedation. The status of NIV intolerance was evaluated using a four-point NIV intolerance score at different timepoints within a 72-h period. The primary outcome was the mitigation rate of NIV intolerance following sedation.
Results: A total of 179 patients were enrolled, with 89 assigned to the REM group and 90 to the DEX group. Baseline characteristics were comparable between the two groups, including NIV intolerance score [3, interquartile range (IQR) 3-3 vs. 3, IQR 3-4, p = 0.180]. The chi-squared test showed that mitigation rate, defined as the proportion of patients who were relieved from their initial intolerance status, was not significant at most timepoints, except for the 15-min timepoint (42% vs. 20%, p = 0.002). However, after considering the time factor, generalized estimating equations showed that the difference was statistically significant, and REM outperformed DEX (odds ratio = 3.31, 95% confidence interval: 1.35-8.12, p = 0.009). Adverse effects, which were not reported in the REM group, were encountered by nine patients in the DEX group, with three instances of bradycardia and six cases of severe hypotension. Secondary outcomes, including NIV failure (5.6% vs. 7.8%, p = 0.564), tracheostomy (1.12% vs. 0%, p = 0.313), ICU LOS (7.7 days, IQR 5.8-12 days vs. 7.0 days, IQR 5-10.6 days, p = 0.219), and in-hospital mortality (1.12% vs. 2.22%, p = 0.567), demonstrated comparability between the two groups.
Conclusions: In summary, our study demonstrated no significant difference between REM and DEX in the percentage of patients who achieved mitigation among cardiac surgery patients with moderate-to-severe NIV intolerance. However, after considering the time factor, REM was significantly superior to DEX. Trial registration ClinicalTrials.gov (NCT04734418), registered on January 22, 2021. URL of the trial registry record: https://register.
Clinicaltrials: gov/prs/app/action/SelectProtocol?sid=S000AM4S&selectaction=Edit&uid=U00038YX&ts=3&cx=eqn1z0 .
(© 2024. The Author(s).)
Databáze: MEDLINE
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