Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial.
Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial.
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DOI：
10.1016/j.jagp.2020.05.006
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发表时间：
2021-01
期刊：
影响因子：
--
通讯作者：
Neufeld KJ
中科院分区：
文献类型：
--
作者：
Oh ES;Leoutsakos JM;Rosenberg PB;Pletnikova AM;Khanuja HS;Sterling RS;Oni JK;Sieber FE;Fedarko NS;Akhlaghi N;Neufeld KJ
术后谵妄与住院时间延长、认知和身体状况恶化等负面后果相关，常伴有睡眠-觉醒障碍。我们的目的是评估褪黑激素受体激动剂ramelteon预防老年骨科手术患者术后谵妄的疗效和短期安全性。一项于2017年3月至2019年6月进行的四盲随机安慰剂对照试验（ClinicalTrials.gov NCT02324153）。三级学术医疗中心。年龄50 ~ 65岁，择期进行初级或翻修性髋关节或膝关节置换术的患者。从手术前夜开始，80名参与者被随机分为口服拉美替恩凝胶帽组或安慰剂组，连续服用3个晚上。训练有素的研究人员从术后第0天（POD）开始，从麻醉恢复到第2天，连续3天进行谵妄评估。谵妄诊断是基于专家小组共识确定的DSM-5标准。在80名参与者中，随机分组后，5人撤回同意（1名安慰剂，4名拉梅尔替恩），4人被排除（4名拉梅尔替恩）。术后两天谵妄发生率为7%(5/71)，拉美替恩与安慰剂无差异：分别为9%（3/33）和5%（2/38）。术后谵妄作为ramelteon治疗组分配函数的校正优势比为1.28 （95% CI 0.21-7.93；z值0.27；p值= 0.79）。两组的不良事件相似。在接受择期原发性或翻修性髋关节或膝关节置换术的老年患者中，雷美替恩对预防术后谵妄无效。
Postoperative delirium, associated with negative consequences including longer hospital stays and worse cognitive and physical outcomes, is frequently accompanied by sleep-wake disturbance. Our objective was to evaluate the efficacy and short-term safety of ramelteon, a melatonin receptor agonist, for the prevention of postoperative delirium in older patients undergoing orthopedic surgery. A quadruple-masked randomized placebo-controlled trial (ClinicalTrials.gov NCT02324153) conducted from March 2017 to June 2019. Tertiary academic medical center. Patients aged >65 years, undergoing elective primary or revision hip or knee replacement. Ramelteon (8 mg) or placebo Eighty participants were randomized to an oral gel cap of ramelteon or placebo for 3 consecutive nights starting the night before surgery. Trained research staff conducted delirium assessments for 3 consecutive days starting on postoperative day (POD) 0, after recovery from anesthesia, and on to POD2. A delirium diagnosis was based upon DSM-5 criteria determined by expert panel consensus. Of 80 participants, 5 withdrew consent (1 placebo, 4 ramelteon) and 4 were excluded (4 ramelteon) after randomization. Delirium incidence during the two days following surgery was 7% (5/71) with no difference between the ramelteon versus placebo: 9% (3/33) and 5% (2/38), respectively. The adjusted odds ratio for postoperative delirium as a function of assignment to the ramelteon treatment arm was 1.28 (95% CI 0.21–7.93;z-value 0.27;p-value= 0.79). Adverse events were similar between the two groups. In older patients undergoing elective primary or revision hip or knee replacement, ramelteon was not efficacious in preventing postoperative delirium.
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影响因子：
168.9
作者：
Inouye, Sharon K.;Westendorp, Rudi G. J.;Saczynski, Jane S.
通讯作者：
Saczynski, Jane S.
影响因子：
168.9
作者：
Cronin, AJ;Keifer, JC;Bixler, EO
通讯作者：
Bixler, EO
影响因子：
8.8
作者：
Jaiswal, Stuti J.;Vyas, Anuja D.;Owens, Robert L.
通讯作者：
Owens, Robert L.
DOI：
10.1523/jneurosci.4673-11.2012
发表时间：
2012-05-02
期刊：
The Journal of neuroscience : the official journal of the Society for Neuroscience
影响因子：
--
作者：
Field RH;Gossen A;Cunningham C
通讯作者：
Cunningham C
影响因子：
3.5
作者：
Auyong, David B.;Allen, Cindy Jo;Hanson, Neil A.
通讯作者：
Hanson, Neil A.