From the Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina (R.Y.K., M.C., T.B., N.T., M.B., M.V.P., M.S.-S., J.P.M.) the Department of Anesthesiology, University of Kentucky School of Medicine, Lexington, Kentucky (M.F.N.).
Anesthesiology. 2019 Jun;130(6):958-970. doi: 10.1097/ALN.0000000000002668.
Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo.
After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1 mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 μg · kg · min for the first hour, 24 μg · kg · min for the second hour, and 10 μg · kg · min for the next 46 h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type.
Among the 420 allocated subjects who returned for 6-week follow-up (lidocaine: N = 211; placebo: N = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (-0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life.
Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks.
心脏手术后认知功能下降较为常见，且在很大一部分患者中持续存在。临床前研究和人体试验表明，静脉注射利多卡因可能对神经损伤有保护作用。因此假设利多卡因给药可降低心脏手术后与安慰剂相比的认知功能下降。
在机构审查委员会批准后，478 名接受心脏手术的患者被纳入这项多中心、前瞻性、随机、双盲、安慰剂对照、平行组试验。受试者随机分为利多卡因 1mg/kg 负荷量，继以持续输注（第 1 小时 48μg·kg·min，第 2 小时 24μg·kg·min，接下来 46 小时 10μg·kg·min）或生理盐水，相同容量和速度变化以保持盲法。使用标准神经认知测试组合在术前和术后 6 周及 1 年评估认知功能。主要结局为术后 6 周内认知功能与基线相比的变化，调整年龄、受教育年限、基线认知、种族和手术类型。
在返回 6 周随访的 420 名（利多卡因组：n=211；安慰剂组：n=209）分配患者中，连续认知评分变化无差异（调整平均差异[95%CI]，0.02[-0.05，0.08]；P=0.626）。在利多卡因组中，6 周时发生认知缺陷（至少一个认知域下降超过 1 个标准差）的比例为 41%（87/211），安慰剂组为 40%（83/209）（调整后的优势比[95%CI]，0.94[0.63，1.41]；P=0.766）。两组之间任何生活质量结局均无差异。在 1 年随访时，认知评分变化、认知缺陷或生活质量仍无差异。
心脏手术期间和手术后静脉内给予利多卡因并未降低术后 6 周时的术后认知功能下降。
