RESUMEN
BACKGROUND: Supraventricular tachycardia during the induction of anesthesia may carry a higher risk. STUDY OBJECTIVE: The aim of this study was to evaluate efficacy and safety of intravenous landiolol in Chinese patients with intraoperative supraventricular tachycardia during anesthesia. DESIGN: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase 2 study. SETTING: Eight sites of Chinese hospitals. PATIENTS: 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. INTERVENTIONS: Patients received landiolol or placebo-0.125 mg kg(-1) min(-1) (1 minute) loadingâ0.04 mg kg(-1) min(-1) (10 minutes) continuous. MEASUREMENTS: 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. MAIN RESULTS: 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. CONCLUSION: 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).