Department of Anesthesiology and Intensive Care Medicine, Charité-Universitaetsmedizin Berlin, Campus Charité Mitte and Campus Virchow-Klinikum, Berlin, Germany.
Intensive Care Med. 2011 Mar;37(3):469-76. doi: 10.1007/s00134-010-2100-5. Epub 2010 Dec 17.
To compare the quality of analgesia provided by a remifentanil-based analgesia regime with that provided by a fentanyl-based regime in critically ill patients.
This was a registered, prospective, two-center, randomized, triple-blind study involving adult medical and surgical patients requiring mechanical ventilation (MV) for more than 24 h. Patients were randomized to either remifentanil infusion or a fentanyl infusion for a maximum of 30 days. Sedation was provided using propofol (and/or midazolam if required).
Primary outcome was the proportion of patients in each group maintaining a target analgesia score at all time points. Secondary outcomes included duration of MV, discharge times, and morbidity. At planned interim analysis (n = 60), 50% of remifentanil patients (n = 28) and 63% of fentanyl patients (n = 32) had maintained target analgesia scores at all time points (p = 0.44). There were no significant differences between the groups with respect to mean duration of ventilation (135 vs. 165 h, p = 0.80), duration of hospital stay, morbidity, or weaning. Interim analysis strongly suggested futility and the trial was stopped.
The use of remifentanil-based analgesia in critically ill patients was not superior regarding the achievement and maintenance of sufficient analgesia compared with fentanyl-based analgesia.
比较基于瑞芬太尼的镇痛方案与基于芬太尼的镇痛方案在危重症患者中的镇痛质量。
这是一项已注册的前瞻性、双中心、随机、三盲研究，纳入需要机械通气（MV）超过 24 小时的成年内科和外科患者。患者随机分为瑞芬太尼输注组或芬太尼输注组，最长治疗时间为 30 天。镇静采用丙泊酚（和/或必要时使用咪达唑仑）。
主要结局是两组患者在所有时间点维持目标镇痛评分的比例。次要结局包括 MV 持续时间、出院时间和发病率。在计划的中期分析（n = 60）中，瑞芬太尼组（n = 28）和芬太尼组（n = 32）各有 50%和 63%的患者在所有时间点维持目标镇痛评分（p = 0.44）。两组之间在通气时间（135 小时对 165 小时，p = 0.80）、住院时间、发病率或撤机方面均无显著差异。中期分析强烈提示无效，试验提前终止。
与基于芬太尼的镇痛方案相比，基于瑞芬太尼的镇痛方案在危重症患者中实现和维持足够镇痛方面并无优势。
