Effects of intracuff and intravenous lignocaine on recovery from anaesthesia after thyroid surgery. A single-centre randomised double-blind placebo-controlled trial (The IOLANT study).

IF 2.9 Q1 ANESTHESIOLOGY
Indian Journal of Anaesthesia Pub Date : 2024-12-01 Epub Date: 2024-12-03 DOI:10.4103/ija.ija_487_24
Sergey M Efremov, Alexey Y Kulikov, Valeria P Govorushkina, Daniil D Sidorov, Alexey A Ladutko, Oleg V Kuleshov
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Abstract

Background and aims: 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.

Methods: 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.

Results: 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) (P = 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.

Conclusion: Neither IVL nor TL improved the QoR from anaesthesia and did not affect electromyographic monitoring in low-risk thyroid surgery.

注射和静脉注射利多卡因对甲状腺术后麻醉恢复的影响。一项单中心随机双盲安慰剂对照试验(IOLANT研究)。
背景和目的:尽管有证据表明局部注射碱化利多卡因可以减少甲状腺手术后喉反射过度的发生率,但其对麻醉恢复质量(QoR)的影响仍然未知。本研究旨在测试与安慰剂相比,局部注射碱化利多卡因是否能改善甲状腺手术后麻醉后的QoR。方法:45岁以上的甲状腺手术患者在全身麻醉下进行肌电图监测,纳入随机、单中心、双盲、安慰剂对照试验。他们被随机分为三组(1:1:1的比例):静脉注射利多卡因(IVL),局部和局部注射利多卡因(TL)和安慰剂。样本量最初设定为231例,但在对110例患者进行中期分析后,发现两组之间没有显著差异,因此提前终止了研究。主要观察指标为术后24小时QoR-40评分。次要结局包括动脉低血压的发生率、急诊时的咳嗽、双谱指数(BIS)值和肌电监测特征。结果:110例患者的中期分析显示,平均QoR-40评分为185(标准偏差(SD): 11.4)(安慰剂组),186.1 (SD: 13.6) (IVL组)和185.1 (SD: 14.3) (TL组)(P = 0.662)。平均差异为1.1 (IVL vs安慰剂,95%CI: -5.03, 7.15, z = 0.347)和0.1 (TL vs安慰剂,95%CI: -6.02, 6.23, z = 0.035)。由于未能证明IVL和TL的优越性,研究因缺乏有效性而终止。在次要结局方面没有发现差异。结论:在低风险甲状腺手术中,IVL和TL均未改善麻醉QoR,且不影响肌电图监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.20
自引率
44.80%
发文量
210
审稿时长
36 weeks
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