After cardiac surgery, post-operative delirium (PoD) is acknowledged to have a significant negative impact on patient outcome. To date, there is no valuable and specific treatment for PoD. Critically ill patients often suffer from poor sleep condition. There is an association between delirium and sleep quality after cardiac surgery. This study aimed to establish whether promoting sleep using an overnight infusion of dexmedetomidine reduces the incidence of delirium after cardiac surgery. Randomized, pragmatic, multicentre, double-blind, placebo controlled trial from January 2019 to July 2021. All adult patients aged 65 years or older requiring elective cardiac surgery were randomly assigned 1:1 either to the dexmedetomidine group or the placebo group on the day of surgery. Dexmedetomidine or matched placebo infusion was started the night after surgery from 8 pm to 8 am and administered every night while the patient remained in ICU, or for a maximum of 7 days. Primary outcome was the occurrence of postoperative delirium (PoD) within the 7 days after surgery. A total of 348 patients provided informed consent, of whom 333 were randomized: 331 patients underwent surgery and were analysed (165 assigned to dexmedetomidine and 166 assigned to placebo). The incidence of PoD was not significantly different between the two groups (12.6% vs. 12.4%, p = 0.97). Patients treated with dexmedetomidine had significantly more hypotensive events (7.3% vs 0.6%; p < 0.01). At 3 months, functional outcomes (Short-form 36, Cognitive failure questionnaire, PCL-5) were comparable between the two groups. In patients recovering from an elective cardiac surgery, an overnight infusion of dexmedetomidine did not decrease postoperative delirium. Trial registration This trial was registered on ClinicalTrials.gov (number: NCT03477344; date: 26th March 2018).

中文翻译：

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对接受心脏手术的患者使用过夜输注右美托咪定预防术后谵妄：一项务实、随机、双盲、安慰剂对照试验

心脏手术后，术后谵妄（PoD）被认为会对患者的预后产生显着的负面影响。迄今为止，PoD 尚无有价值且特异性的治疗方法。危重病人往往睡眠状况不佳。谵妄与心脏手术后的睡眠质量之间存在关联。本研究旨在确定过夜输注右美托咪定促进睡眠是否可以降低心脏手术后谵妄的发生率。2019年1月至2021年7月进行的随机、务实、多中心、双盲、安慰剂对照试验。所有年龄在65岁或以上、需要择期心脏手术的成年患者在当天以1:1的比例随机分配到右美托咪定组或安慰剂组的手术。手术后晚上 8 点至上午 8 点开始输注右美托咪定或匹配的安慰剂，并在患者留在 ICU 期间每晚输注，或最多 7 天。主要结局是术后 7 天内发生术后谵妄 (PoD)。共有 348 名患者提供了知情同意书，其中 333 名患者被随机分组​​：331 名患者接受了手术并进行了分析（165 名患者分配至右美托咪定，166 名患者分配至安慰剂）。两组之间的 PoD 发生率没有显着差异（12.6% vs. 12.4%，p = 0.97）。使用右美托咪定治疗的患者低血压事件明显增多（7.3% vs 0.6%；p < 0.01）。3 个月时，两组的功能结果（简式 36，认知障碍问卷，PCL-5）具有可比性。在从择期心脏手术中恢复的患者中，过夜输注右美托咪定并不能减少术后谵妄。试验注册 该试验已在 ClinicalTrials.gov 上注册（编号：NCT03477344；日期：2018 年 3 月 26 日）。