静脉注射利多卡因不能改善心脏手患者术后神经系统临床结局：随机对照试验
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Intravenous Lidocaine Does Not Improve Neurologic Outcomes after Cardiac Surgery ： A Randomized Controlled Trial
背景与目的
心脏手术患者术后经常发生认知功能下降，并持续存在于相当大一部分患者中。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起到保护作用。本研究假设与安慰剂相比，心脏手术后使用利多卡因可以减少认知功能下降。
方 法
在机构评审委员会批准后，这项多中心、前瞻性、随机、双盲、安慰剂对照的平行分组试验纳入478名接受心脏手术的患者。受试者在麻醉诱导后随机注入1 mg/kg的利多卡因，然后持续输注(第一小时48μg·kg-1·min-1，第2小时24μg·kg-1·min-1，接下来的46小时输注10μg·kg-1·min-1）或者按同样的体积和速度输注生理盐水，并保持医患双方对此不知情。所有患者术前、术后6周、术后1年用神经认知测验(neurocognitive test)对患者的认知功能进行评估。主要结果为认知功能在基线与术后6周时的改变，并根据年龄、受教育年限、基线认知、种族、手术方式等因素进行调整，观察两组患者的认知功能变化，结果与术前相比，差异有显著性(P<0.0 5，P<0.0 1，P<0.0 5)，术后6周认知功能无明显变化(P>0.0 5)。
结 果
420名受试者进行6周的随访(利多卡因：211名；安慰剂：209名)，发现连续认知评分变化没有差异(调整后的平均差[95%CI]，0.02(0.05，0.08)；6周时利多卡因组有41%(87/211)的患者发生认知功能障碍(至少在一个认知域中有大于1 SD的下降)，而对照组有40%(83/209)的患者在6周时出现认知缺陷(至少在一个认知域中有大于1 SD的下降)。安慰剂组(调整后的优势比[95%CI]，0.94[0.63，1.41]；两组患者的生活质量结局无差异。随访1年，在认知评分变化、认知功能缺损、生活质量等方面差异无显著性(P>0.0 5)，但差异无统计学意义(P>0.0 5)。
结 论
心脏手术期间和术后静脉注射利多卡因并不能减少术后6周的认知功能下降。
原始文献摘要
Rebecca Y. Klinger，Mary Cooter, Tiffany Bisanar；
Intravenous Lidocaine Does Not Improve Neurologic Outcomes after Cardiac Surgery ： A Randomized Controlled Trial；[J]. Anesthesiology 2019; 130:958–70.
Background: 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.
Methods: 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 1 · min 1 for the first hour, 24 μg · kg 1 · min 1 for the second hour, and 10 μg · kg 1 · min 1 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.
Results: 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.
Conclusions: Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks.
麻醉学文献进展分享
贵州医科大学高鸿教授课题组
翻译：余晓旭 编辑：何幼芹 审校：王贵龙