Mathew Joseph P, Mackensen G Burkhard, Phillips-Bute Barbara, Grocott Hilary P, Glower Donald D, Laskowitz Daniel T, Blumenthal James A, Newman Mark F
Department of Anesthesiology, Duke University Medical Center, Durham, NC 27710, USA.
Stroke. 2009 Mar;40(3):880-7. doi: 10.1161/STROKEAHA.108.531236. Epub 2009 Jan 22.
Cognitive decline after cardiac surgery remains common and diminishes patients' quality of life. Based on experimental and clinical evidence, this study assessed the potential of intravenously administered lidocaine to reduce postoperative cognitive dysfunction after cardiac surgery using cardiopulmonary bypass.
After IRB approval, 277 patients undergoing cardiac surgery were enrolled into this prospective, randomized, double-blinded placebo controlled clinical trial. Subjects were randomized to receive: (1) Lidocaine as a 1 mg/kg bolus followed by a continuous infusion through 48 hours postoperatively, or (2) Placebo bolus and infusion. Cognitive function was assessed preoperatively and again at 6 weeks and 1 year postoperatively. The effect of lidocaine on postoperative cognition was tested using multivariable regression modeling; P<0.05 was considered significant.
Among the 241 allocated subjects (Lidocaine: n=114; Placebo: n=127), the incidence of cognitive deficit in the lidocaine group was 45.5% versus 45.7% in the placebo group (P=0.97). Multivariable analysis revealed a significant interaction between treatment group and diabetes, such that diabetic subjects receiving lidocaine were more likely to suffer cognitive decline (P=0.004). Secondary analysis identified total lidocaine dose (mg/kg) as a significant predictor of cognitive decline and also revealed a protective effect of lower dose lidocaine in nondiabetic subjects.
Lidocaine administered during and after cardiac surgery does not reduce the high rate of postoperative cognitive dysfunction. Higher doses of lidocaine and diabetic status were independent predictors of cognitive decline. Protective effects of lower dose lidocaine in nondiabetic subjects need to be further evaluated.
心脏手术后认知功能下降仍然很常见,会降低患者的生活质量。基于实验和临床证据,本研究评估了静脉注射利多卡因在心脏手术体外循环后减少术后认知功能障碍的潜力。
经机构审查委员会(IRB)批准后,277例接受心脏手术的患者被纳入这项前瞻性、随机、双盲、安慰剂对照临床试验。受试者被随机分为:(1)利多卡因组,静脉推注1mg/kg,术后持续输注48小时;(2)安慰剂推注和输注组。术前以及术后6周和1年对认知功能进行评估。使用多变量回归模型测试利多卡因对术后认知的影响;P<0.05被认为具有统计学意义。
在241例分配的受试者中(利多卡因组:n=114;安慰剂组:n=127),利多卡因组认知缺陷的发生率为45.5%,而安慰剂组为45.7%(P=0.97)。多变量分析显示治疗组与糖尿病之间存在显著交互作用,即接受利多卡因的糖尿病受试者更易出现认知功能下降(P=0.004)。二次分析确定利多卡因总剂量(mg/kg)是认知功能下降的重要预测因素,还显示低剂量利多卡因对非糖尿病受试者具有保护作用。
心脏手术期间及术后使用利多卡因并不能降低术后认知功能障碍的高发生率。较高剂量的利多卡因和糖尿病状态是认知功能下降的独立预测因素。低剂量利多卡因对非糖尿病受试者的保护作用需要进一步评估。