Efremov Sergey M, Kulikov Alexey Y, Govorushkina Valeria P, Sidorov Daniil D, Ladutko Alexey A, Kuleshov Oleg V
Anaesthesiology Department, Saint Petersburg State University Hospital, Saint-Petersburg, Russian Federation.
Endocrine Surgery Department, Saint Petersburg State University Hospital, Saint-Petersburg, Russian Federation.
Indian J Anaesth. 2024 Dec;68(12):1055-1061. doi: 10.4103/ija.ija_487_24. Epub 2024 Dec 3.
Despite evidence that local intracuff alkalinised lignocaine may reduce the incidence of exaggerated laryngeal reflexes after thyroid surgery, its effects on the quality of recovery (QoR) from anaesthesia remain unknown. This study aimed to test if local intracuff alkalinised lignocaine improves the QoR from anaesthesia after thyroid surgery compared to placebo.
Patients over 45 years old scheduled for thyroid surgery with electromyographic monitoring under general anaesthesia were enroled in a randomised, single-centre, double-blind, placebo-controlled trial. They were randomised into three groups (1:1:1 ratio): intravenous lignocaine (IVL), topical and intracuff lignocaine (TL), and placebo. The sample size was initially set at 231, but the study was terminated early after an interim analysis of 110 patients showed no significant difference between groups. The primary outcome was the QoR-40 score 24 hours post-surgery. Secondary outcomes included rates of arterial hypotension, coughing during emergence, bispectral index (BIS) values, and electromyographic monitoring characteristics.
An interim analysis after 110 patients showed mean QoR-40 scores of 185 (standard deviation(SD): 11.4) (placebo), 186.1 (SD: 13.6) (IVL), and 185.1 (SD: 14.3) (TL) ( = 0.662). Mean differences were 1.1 (IVL vs placebo, 95%CI: -5.03, 7.15, z = 0.347) and 0.1 (TL vs placebo, 95%CI: -6.02, 6.23, z = 0.035). The study was stopped due to lack of effectiveness as the superiority of IVL and TL was not demonstrated. No differences were found in secondary outcomes.
Neither IVL nor TL improved the QoR from anaesthesia and did not affect electromyographic monitoring in low-risk thyroid surgery.
尽管有证据表明局部袖带内碱化利多卡因可降低甲状腺手术后喉反射亢进的发生率,但其对麻醉恢复质量(QoR)的影响仍不清楚。本研究旨在测试与安慰剂相比,局部袖带内碱化利多卡因是否能改善甲状腺手术后的麻醉恢复质量。
将计划在全身麻醉下进行甲状腺手术并接受肌电图监测的45岁以上患者纳入一项随机、单中心、双盲、安慰剂对照试验。他们被随机分为三组(1:1:1比例):静脉注射利多卡因(IVL)、局部和袖带内利多卡因(TL)以及安慰剂。样本量最初设定为231,但在对110例患者进行中期分析显示各组之间无显著差异后,该研究提前终止。主要结局是术后24小时的QoR-40评分。次要结局包括动脉低血压发生率、苏醒期咳嗽发生率、脑电双频指数(BIS)值以及肌电图监测特征。
对110例患者进行中期分析显示,安慰剂组的平均QoR-40评分为185(标准差(SD):11.4),IVL组为186.1(SD:13.6),TL组为185.1(SD:14.3)(P = 0.662)。IVL组与安慰剂组的平均差异为1.1(95%CI:-5.03,7.15,z = 0.347),TL组与安慰剂组的平均差异为0.1(95%CI:-6.02,6.23,z = 0.035)。由于未证明IVL和TL的优越性,该研究因缺乏有效性而停止。次要结局未发现差异。
在低风险甲状腺手术中,IVL和TL均未改善麻醉恢复质量,也未影响肌电图监测。