Department of Anesthesiology, Erasmus Medical Centre, Rotterdam, The Netherlands.
Eur J Vasc Endovasc Surg. 2011 Sep;42(3):317-23. doi: 10.1016/j.ejvs.2011.05.001. Epub 2011 May 31.
This article describes the rationale and design of the DECREASE-XIII trial, which aims to evaluate the potential of esmolol infusion, an ultra-short-acting beta-blocker, during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery.
A double-blind, placebo-controlled, randomised trial.
MATERIALS & METHODS: A total of 260 vascular surgery patients will be randomised to esmolol or placebo as an add-on to standard medical care, including chronic low-dose beta-blockers. Esmolol is titrated to maintain a heart rate within a target window of 60-80 beats per minute for 24 h from the induction of anaesthesia. Heart rate and ischaemia are assessed by continuous 12-lead electrocardiographic monitoring for 72 h, starting 1 day prior to surgery. The primary outcome measure is duration of heart rate outside the target window during infusion of the study drug. Secondary outcome measures will be the efficacy parameters of occurrence of cardiac ischaemia, troponin T release, myocardial infarction and cardiac death within 30 days after surgery and safety parameters such as the occurrence of stroke and hypotension.
This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters.
本文介绍了 DECREASE-XIII 试验的原理和设计，该试验旨在评估依托咪酯输注（一种超短效β受体阻滞剂）作为慢性低剂量β受体阻滞剂治疗的附加治疗，在大型血管手术期间维持围手术期血液动力学稳定的潜力。
双盲、安慰剂对照、随机试验。
共 260 例血管外科患者将随机分为依托咪酯或安慰剂组，作为标准医疗护理的附加治疗，包括慢性低剂量β受体阻滞剂。依托咪酯的滴定剂量旨在将心率维持在麻醉诱导后 24 小时内 60-80 次/分钟的目标窗口内。通过连续 12 导联心电图监测评估心率和缺血情况，从手术前 1 天开始监测 72 小时。主要结局指标是研究药物输注期间心率超出目标窗口的持续时间。次要结局指标将是手术后 30 天内心脏性缺血、肌钙蛋白 T 释放、心肌梗死和心脏死亡的疗效参数以及中风和低血压等安全性参数。
本研究将提供关于依托咪酯滴定在慢性β受体阻滞剂使用者中用于严格心率控制和减少血管手术患者缺血的疗效数据，以及安全性参数的数据。
