University Clinic for Anaesthesiology and Operative Intensive Care Medicine Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany.
Trials. 2012 Aug 10;13:135. doi: 10.1186/1745-6215-13-135.
State of the art sedation concepts on intensive care units (ICU) favor propofol for a time period of up to 72 h and midazolam for long-term sedation. However, intravenous sedation is associated with complications such as development of tolerance, insufficient sedation quality, gastrointestinal paralysis, and withdrawal symptoms including cognitive deficits. Therefore, we aimed to investigate whether sevoflurane as a volatile anesthetic technically implemented by the anesthetic-conserving device (ACD) may provide advantages regarding 'weaning time', efficiency, and patient's safety when compared to standard intravenous sedation employing propofol.
METHOD/DESIGN: This currently ongoing trial is designed as a two-armed, monocentric, randomized prospective phase II study including intubated intensive care patients with an expected necessity for sedation exceeding 48 h. Patients are randomly assigned to either receive intravenous sedation with propofol or sevoflurane employing the ACD. Primary endpoint is the comparison of the 'weaning time' defined as the time required from discontinuation of the sedating agent until sufficient spontaneous breathing occurs. Moreover, sedation depth evaluated by Richmond Agitation Sedation Scale and parameters of patient's safety (that is, vital signs, laboratory monitoring of organ function) as well as the duration of mechanical ventilation and overall stay on the ICU are analyzed and compared. An intention-to-treat analysis will be carried out with all patients for whom it will be possible to define a wake-up time. In addition, a per-protocol analysis is envisaged. Completion of patient recruitment is expected by the end of 2012.
This clinical study is designed to evaluate the impact of sevoflurane during long-term sedation of critically ill patients on 'weaning time', efficiency, and patient's safety compared to the standard intravenous sedation concept employing propofol.
EudraCT2007-006087-30; ISRCTN90609144.
重症监护病房（ICU）的最新镇静理念主张对于 72 小时以内的镇静采用丙泊酚，对于长期镇静采用咪达唑仑。然而，静脉镇静会引起并发症，如出现耐药性、镇静质量不足、胃肠道瘫痪以及戒断症状，包括认知缺陷。因此，我们旨在研究七氟醚作为一种挥发性麻醉剂，在通过麻醉节省装置（ACD）实施时，与采用丙泊酚的标准静脉镇静相比，在“撤机时间”、效率和患者安全性方面是否具有优势。
方法/设计：这是一项正在进行的、两臂、单中心、随机前瞻性 II 期研究，纳入预计需要镇静超过 48 小时的气管插管重症监护患者。患者被随机分配接受丙泊酚或七氟醚静脉镇静，通过 ACD 实施。主要终点是比较“撤机时间”，定义为从停止镇静药物到出现足够自主呼吸所需的时间。此外，还分析和比较镇静深度（采用 Richmond 躁动-镇静量表评估）和患者安全性参数（即生命体征、器官功能的实验室监测）以及机械通气时间和 ICU 总停留时间。将对所有能够确定唤醒时间的患者进行意向治疗分析。此外，还设想了一项符合方案分析。预计 2012 年底完成患者招募。
这项临床研究旨在评估在重症患者的长期镇静中使用七氟醚与采用丙泊酚的标准静脉镇静概念相比，对“撤机时间”、效率和患者安全性的影响。
EudraCT2007-006087-30；ISRCTN90609144。
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