Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy*
Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy*
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DOI：
10.1097/ccm.0000000000004004
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发表时间：
2019-12-01
影响因子：
8.8
通讯作者：
Owens, Robert L.
中科院分区：
文献类型：
--
作者：
Jaiswal, Stuti J.;Vyas, Anuja D.;Owens, Robert L.
目的：评估雷美替酮在预防谵妄方面的疗效，谵妄是一种与围手术期ICU环境中发病率和死亡率增加相关的急性神经精神疾病。设计：单组、随机、双盲、安慰剂对照试验。地点：位于加州拉霍亚的学术医学中心。患者：≥ 18岁接受择期肺血栓动脉内膜切除术的患者。干预措施：Ramelteon 8 mg或匹配的安慰剂从手术前一晚开始，在ICU最多持续6晚。测量和主要结果：使用意识模糊评估方法-ICU每天测量两次谵妄事件。安全性结局是通过里士满躁动-镇静量表评估的无昏迷天数。120名参与者入组，117名参与者完成分析。安慰剂组58例患者中有22例发生谵妄，而雷美替安组59例患者中有19例发生谵妄（相对风险，0.8; 95%CI，0.5-1.4; p = 0.516）。通过无谵妄天数评估的谵妄持续时间在两组中也相似（安慰剂中位2 d [四分位距，2-3 d] vs雷美替翁3 d [2-5 d]; p = 0.181）。两组的无昏迷天数也相似（安慰剂中位2天[四分位距，1-3天] vs雷美替翁3天[2-4天]; p = 0.210）。我们发现，所有安慰剂组与雷美替安组的ICU住院时间（中位数4 d [四分位距，3-5 d] vs 4 d [3-6 d]; p = 0.349）或住院死亡率（4 vs 3例死亡;相对风险比，0.7; 95%CI，0.2-3.2; p = 0.717）均无差异。结论：Ramelteon 8 mg不能预防择期心脏手术患者的术后谵妄。
Objectives: To assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the perioperative, ICU setting. Design: Parallel-arm, randomized, double-blinded, placebo-controlled trial. Setting: Academic medical center in La Jolla, California. Patients: Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy. Interventions: Ramelteon 8 mg or matching placebo starting the night prior to surgery and for a maximum of six nights while in the ICU. Measurements and Main Results: Incident delirium was measured twice daily using the Confusion Assessment Method-ICU. The safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale. One-hundred twenty participants were enrolled and analysis completed in 117. Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516). Delirium duration, as assessed by the number of delirium-free days was also similar in both groups (placebo median 2 d [interquartile range, 2-3 d] vs ramelteon 3 d [2-5 d]; p = 0.181). Coma-free days was also similar between groups (placebo median 2 d [interquartile range, 1-3 d] vs ramelteon 3 d [2-4 d]; p = 0.210). We found no difference in ICU length of stay (median 4 d [interquartile range, 3-5 d] vs 4 d [3-6 d]; p = 0.349), or in-hospital mortality (four vs three deaths; relative risk ratio, 0.7; 95% CI, 0.2-3.2; p = 0.717), all placebo versus ramelteon, respectively. Conclusions: Ramelteon 8 mg did not prevent postoperative delirium in patients admitted for elective cardiac surgery.