术前经鼻右美托咪定对行冠状动脉旁路移植术患者术后心肌损伤的影响。
完整摘要 · 中文译文
目的：评价术前经鼻给予右美托咪定对体外循环冠状动脉旁路移植术（CABG）患者术后心肌损伤生物标志物的影响。 患者与方法：在这项随机、双盲、安慰剂对照试验中，70例接受体外循环CABG的患者被分配在手术前夜睡前30分钟及麻醉诱导前30分钟接受经鼻右美托咪定（1 μg/kg）或生理盐水。主要结局为术后24小时血清高敏心肌肌钙蛋白T（hs-cTnT）。次要结局包括围术期心脏生物标志物、术前睡眠质量、术后谵妄及不良事件。 结果：对于预设的主要结局，右美托咪定组术后24小时hs-cTnT浓度显著低于对照组（估计边际均值，170.29 vs 357.29 ng/L；P < 0.001）。右美托咪定组术后肌酸激酶-MB（CK-MB）浓度亦较低（均P < 0.05）。N末端B型利钠肽原显示出显著的组别×时间交互作用（P = 0.030），尽管各术后时间点的组间差异不显著。右美托咪定组利兹睡眠评价问卷评分较高（62 [60-64] vs 44 [41-50]；P < 0.001），术后谵妄发生率较低（14.3% vs 37.1%；P = 0.029）。不良事件、机械通气时长及重症监护病房（ICU）住院时长在组间无显著差异。 结论 结论：在这项单中心试验中，术前接受两剂经鼻右美托咪定与较低的术后高敏心肌肌钙蛋白T（hs-cTnT）和肌酸激酶-MB（CK-MB）浓度、更好的主观术前睡眠质量以及观察到的较低术后谵妄发生率相关。这些发现为初步结果，需要在更大规模、把握度充分的多中心随机试验中加以证实，以确定这些生物标志物的降低是否能转化为具有临床意义的心血管获益。 试验注册：中国临床试验注册中心，ChiCTR2500111431。
完整摘要 · 英文原文
PURPOSE: To evaluate the effects of preoperative intranasal dexmedetomidine on postoperative myocardial injury biomarkers in patients undergoing on-pump coronary artery bypass grafting (CABG). PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled trial, 70 patients undergoing on-pump CABG were assigned to receive intranasal dexmedetomidine (1 μg/kg) or saline 30 min before bedtime on the night before surgery and again 30 min before anesthesia induction. The primary outcome was serum high-sensitivity cardiac troponin T (hs-cTnT) at 24 h after surgery. Secondary outcomes included perioperative cardiac biomarkers, preoperative sleep quality, postoperative delirium, and adverse events. RESULTS: For the prespecified primary outcome, hs-cTnT concentrations at 24 h after surgery were significantly lower in the dexmedetomidine group than in the control group (estimated marginal means, 170.29 vs 357.29 ng/L; P < 0.001). Postoperative creatine kinase-MB (CK-MB) concentrations were also lower in the dexmedetomidine group (all P < 0.05). N-terminal pro-B-type natriuretic peptide showed a significant group-by-time interaction (P = 0.030), although between-group differences at individual postoperative time points were not significant. The dexmedetomidine group had higher Leeds Sleep Evaluation Questionnaire scores (62 [60-64] vs 44 [41-50]; P < 0.001) and a lower incidence of postoperative delirium (14.3% vs 37.1%; P = 0.029). Adverse events, mechanical ventilation duration, and intensive care unit (ICU) length of stay did not differ significantly between groups. CONCLUSION: In this single-center trial, two-dose preoperative intranasal dexmedetomidine was associated with lower postoperative hs-cTnT and CK-MB concentrations, better subjective preoperative sleep quality, and a lower observed incidence of postoperative delirium. These findings are preliminary and require confirmation in larger, adequately powered multicenter randomized trials to determine whether the biomarker reductions translate into clinically meaningful cardiovascular benefits. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2500111431.