Xiao Jie, He Ping, Zou Qiaoqun, Zhao Yanhua, Xue Zhanggang, Deng Xiaoming, Li Shitong, Guo Qunlian, Tao Guocai, Yang Tiande, Lang Zhixun, He Jia, Wang Xiangrui
Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Department of Anesthesiology, Zhongshan Hospital of Fudan University, Shanghai, China.
J Clin Anesth. 2015 Mar;27(2):120-8. doi: 10.1016/j.jclinane.2014.07.003. Epub 2014 Nov 28.
Supraventricular tachycardia during the induction of anesthesia may carry a higher risk.
The aim of this study was to evaluate efficacy and safety of intravenous landiolol in Chinese patients with intraoperative supraventricular tachycardia during anesthesia.
A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase 2 study.
Eight sites of Chinese hospitals.
Men and women aged 18 to 70 years with the intraoperative supraventricular tachycardia (heart rate [HR], ≥100 beats/min) or the supraventricular tachycardia outside of the sinus tachycardia lasting more than 1 minute.
Patients received landiolol or placebo-0.125 mg kg(-1) min(-1) (1 minute) loading→0.04 mg kg(-1) min(-1) (10 minutes) continuous.
The proportion of patients receiving rescue medication (esmolol) when the reduction of HR did not exceed 10% after intravenous landiolol for 5 minutes. Other secondary efficacy end points include HR, blood pressure, rate pressure product, and electrocardiogram; the improvement of supraventricular tachycardia; the time it takes for the decrease of the HR to reach more than 10%; and the time it takes for the HR to reach <100 beats/min.
Efficacy and safety were evaluated for 240 patients who received study drug. Lower proportions of patients received rescue medication in the landiolol group (7.63%) compared with that in the placebo group (80.33%) (P < .0001). Suppression of HR and rate pressure product was generally more potent(P < .0001), and higher proportions of patients improved supraventricular tachycardia (P < .0001) in the landiolol group. The most frequent adverse event was hypotension.
Intravenous landiolol (loading dose of 0.125 mg/kg) may effectively control intraoperative supraventricular tachycardia during anesthesia. It inhibited the increases in HR during the induction of anesthesia. The effect of landiolol on blood pressure was minimal without decreasing diastolic blood pressure and with the minor reduction of systolic blood pressure (ClinicalTrials.gov number, ChiCTR-TRC-12003021).
麻醉诱导期间的室上性心动过速可能具有更高风险。
本研究旨在评估静脉注射兰地洛尔对中国麻醉期间发生术中室上性心动过速患者的有效性和安全性。
一项随机、双盲、安慰剂对照、平行组、多中心2期研究。
中国8家医院。
年龄在18至70岁之间，术中发生室上性心动过速（心率[HR]≥100次/分钟）或非窦性心动过速的室上性心动过速持续超过1分钟的男性和女性。
患者接受兰地洛尔或安慰剂——0.125mg·kg⁻¹·min⁻¹（1分钟）负荷剂量→0.04mg·kg⁻¹·min⁻¹（10分钟）持续输注。
静脉注射兰地洛尔5分钟后心率降低未超过10%时接受抢救药物（艾司洛尔）的患者比例。其他次要疗效终点包括心率、血压、心率血压乘积和心电图；室上性心动过速的改善情况；心率降低达到10%以上所需时间；以及心率降至<100次/分钟所需时间。
对240例接受研究药物的患者评估了有效性和安全性。与安慰剂组（80.33%）相比，兰地洛尔组接受抢救药物的患者比例更低（7.63%）（P<.0001）。兰地洛尔组心率和心率血压乘积的抑制作用通常更强（P<.0001），改善室上性心动过速的患者比例更高（P<.0001）。最常见的不良事件是低血压。
静脉注射兰地洛尔（负荷剂量0.125mg/kg）可有效控制麻醉期间的术中室上性心动过速。它抑制了麻醉诱导期间心率的升高。兰地洛尔对血压的影响最小，不降低舒张压，收缩压略有降低（ClinicalTrials.gov编号，ChiCTR-TRC-12003021）。
