Muellejans Bernd, López Angel, Cross Michael H, Bonome César, Morrison Lachlan, Kirkham Andrew J T
Anaesthesiology & Intensive Care Medicine, Klinikum Karlsburg, Herz-und Diabeteszentrum Mecklenburg-Vorpommern Klinik für Anaesthesiologie und Intensivmedizin, Karlsburg, Germany.
Crit Care. 2004 Feb;8(1):R1-R11. doi: 10.1186/cc2398. Epub 2003 Nov 20.
This double-blind, randomized, multicentre study was conducted to compare the efficacy and safety of remifentanil and fentanyl for intensive care unit (ICU) sedation and analgesia.
Intubated cardiac, general postsurgical or medical patients (aged >/= 18 years), who were mechanically ventilated for 12-72 hours, received remifentanil (9 microgram/kg per hour; n = 77) or fentanyl (1.5 microgram/kg per hour; n = 75). Initial opioid titration was supplemented with propofol (0.5 mg/kg per hour), if required, to achieve optimal sedation (i.e. a Sedation-Agitation Scale score of 4).
The mean percentages of time in optimal sedation were 88.3% for remifentanil and 89.3% for fentanyl (not significant). Patients with a Sedation-Agitation Scale score of 4 exhibited significantly less between-patient variability in optimal sedation on remifentanil (variance ratio of fentanyl to remifentanil 1.84; P = 0.009). Of patients who received fentanyl 40% required propofol, as compared with 35% of those who received remifentanil (median total doses 683 mg and 378 mg, respectively; P = 0.065). Recovery was rapid (median time to extubation: 1.1 hours for remifentanil and 1.3 hours for fentanyl; not significant). Remifentanil patients who experienced pain did so for significantly longer during extubation (6.5% of the time versus 1.4%; P = 0.013), postextubation (10.2% versus 3.6%; P = 0.001) and post-treatment (13.5% versus 5.1%; P = 0.001), but they exhibited similar haemodynamic stability with no significant differences in adverse event incidence.
Analgesia based sedation with remifentanil titrated to response provided effective sedation and rapid extubation without the need for propofol in most patients. Fentanyl was similar, probably because the dosing algorithm demanded frequent monitoring and adjustment, thereby preventing over-sedation. Rapid offset of analgesia with remifentanil resulted in a greater incidence of pain, highlighting the need for proactive pain management when transitioning to longer acting analgesics, which is difficult within a double-blind study but would be quite possible under normal circumstances.
本双盲、随机、多中心研究旨在比较瑞芬太尼和芬太尼用于重症监护病房（ICU）镇静和镇痛的疗效及安全性。
年龄≥18岁、需机械通气12 - 72小时的插管心脏手术、普通外科手术后或内科患者，接受瑞芬太尼（9微克/千克/小时；n = 77）或芬太尼（1.5微克/千克/小时；n = 75）治疗。必要时，初始阿片类药物滴定补充丙泊酚（0.5毫克/千克/小时）以达到最佳镇静效果（即镇静 - 躁动评分4分）。
达到最佳镇静状态的平均时间百分比，瑞芬太尼组为88.3%，芬太尼组为89.3%（无显著差异）。镇静 - 躁动评分为4分的患者中，瑞芬太尼组在最佳镇静状态下患者间变异性显著更小（芬太尼与瑞芬太尼的方差比为1.84；P = 0.009）。接受芬太尼的患者中有40%需要丙泊酚，而接受瑞芬太尼的患者中这一比例为35%（中位数总剂量分别为683毫克和378毫克；P = 0.065）。恢复迅速（拔管中位时间：瑞芬太尼组为1.1小时，芬太尼组为1.3小时；无显著差异）。经历疼痛的瑞芬太尼组患者在拔管期间（6.5%的时间对1.4%；P = 0.013）、拔管后（10.2%对3.6%；P = 0.001）和治疗后（13.5%对5.1%；P = 0.001）疼痛持续时间显著更长，但两组血流动力学稳定性相似，不良事件发生率无显著差异。
根据反应滴定瑞芬太尼进行基于镇痛的镇静可提供有效的镇静效果并快速拔管，大多数患者无需丙泊酚。芬太尼情况类似，可能是因为给药算法要求频繁监测和调整，从而防止过度镇静。瑞芬太尼镇痛作用快速消退导致疼痛发生率更高，这突出了在转换为长效镇痛药时积极进行疼痛管理的必要性，这在双盲研究中很难做到，但在正常情况下是可行的。
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