夜间右美托咪定减轻心脏手术后的重症监护后综合征：一项前瞻性随机对照临床试验。
Nocturnal dexmedetomidine alleviates post-intensive care syndrome following cardiac surgery: a prospective randomized controlled clinical trial.
机构信息
Department of Cardiac Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, No. 9677 Jingshi Road, Jinan, 250021, Shandong, China.
Department of Biostatistics, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.
出版信息
BMC Med. 2021 Dec 6;19(1):306. doi: 10.1186/s12916-021-02175-2.
BACKGROUND
Dexmedetomidine is a sedative agent that may have the potential to reduce the risk of post-intensive care syndrome (PICS). This study aimed to establish whether prophylactic nocturnal dexmedetomidine safely reduces postoperative PICS incidence and to develop an easy-to-use model for predicting the risk of PICS following cardiac surgery.
METHODS
This was a single-center, double-blind, randomized, prospective, placebo-controlled trial. Patients undergoing cardiac surgery were randomly assigned (1:1) to dexmedetomidine or placebo (normal saline) groups between January 2019 and July 2020. Dexmedetomidine or a similar volume of saline was administered, with an infusion rate up to 1.2 μg/kg/h until the RASS remained between - 1 and 0. The primary study endpoint was PICS incidence at 6 months follow-up, as defined by cognitive, physical, or psychological impairments.
RESULTS
We assessed 703 individuals for eligibility, of whom 508 were enrolled. Of these, there were 251 in the dexmedetomidine group and 257 in the placebo group that received the trial agent, forming a modified intention-to-treat population. PICS incidence at 6-month follow-up was significantly decreased in the dexmedetomidine group (54/251, 21.5%) relative to the placebo group (80/257, 31.1%) (odds ratio [OR] 0.793, 95% CI 0.665-0.945; p = 0.014). Psychological impairment was significantly reduced in the dexmedetomidine group relative to the placebo group (18.7% vs. 26.8%, OR 0.806, CI 0.672-0.967, p = 0.029). However, dexmedetomidine treatment was associated with a higher rate of hypotension. A nomogram revealed that age, education, a medical history of diabetes and smoking, dexmedetomidine treatment, postoperative atrial fibrillation, and sequential organ failure assessment scores at 8 h post-surgery were independent predictors of PICS.
CONCLUSIONS
Prophylactic nocturnal dexmedetomidine administration significantly reduced PICS incidence by a marked reduction in psychological impairment within a 6-month follow-up period.
TRIAL REGISTRATION
ChiCTR, ChiCTR1800014314 . Registered 5 January 2018, http://www.chictr.org.cn/index.aspx.
背景
右美托咪定是一种镇静剂，可能具有降低重症监护后综合征（PICS）风险的潜力。本研究旨在确定预防性夜间使用右美托咪定是否能安全降低心脏手术后 PICS 的发生率，并开发一种易于使用的预测心脏手术后 PICS 风险的模型。
方法
这是一项单中心、双盲、随机、前瞻性、安慰剂对照试验。2019 年 1 月至 2020 年 7 月期间，将接受心脏手术的患者随机分为右美托咪定组（n=251）或安慰剂组（生理盐水，n=257）。右美托咪定或等量生理盐水以 1.2μg/kg/h 的速度输注，直至 RASS 保持在-1 到 0 之间。主要研究终点是 6 个月随访时 PICS 的发生率，定义为认知、身体或心理障碍。
结果
我们评估了 703 名符合条件的患者，其中 508 名入选。其中，右美托咪定组 251 名，安慰剂组 257 名接受了试验药物，形成了改良意向治疗人群。与安慰剂组（80/257，31.1%）相比，右美托咪定组（54/251，21.5%）6 个月随访时 PICS 的发生率显著降低（比值比 [OR]0.793，95%CI0.665-0.945；p=0.014）。与安慰剂组相比，右美托咪定组的心理障碍发生率显著降低（18.7% vs. 26.8%，OR0.806，95%CI0.672-0.967，p=0.029）。然而，右美托咪定治疗与低血压发生率较高有关。列线图显示，年龄、教育程度、糖尿病和吸烟史、右美托咪定治疗、术后心房颤动和术后 8 小时序贯器官衰竭评估评分是 PICS 的独立预测因素。
结论
预防性夜间使用右美托咪定可显著降低 PICS 的发生率，在 6 个月的随访期内显著降低心理障碍发生率。
试验注册
ChiCTR，ChiCTR1800014314。2018 年 1 月 5 日注册，http://www.chictr.org.cn/index.aspx。
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