Stevanovic Ana, Rossaint Rolf, Keszei András P, Fritz Harald, Fröba Gebhard, Pühringer Friedrich, Coburn Mark
Department of Anesthesiology, University Hospital RWTH Aachen, Pauwelsstr. 30, 52074, Aachen, Germany.
Department of Medical Informatics, University Hospital RWTH Aachen, Pauwelsstr. 30, 52074, Aachen, Germany.
Trials. 2015 Jul 26;16:316. doi: 10.1186/s13063-015-0855-2.
The use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefore, we aim to compare desflurane with other commonly used anesthetics, sevoflurane and propofol, in a sufficiently powered RCT. We hypothesize that desflurane is noninferior regarding the frequency of upper airway events and superior regarding the emergence times to sevoflurane and propofol.
METHODS/DESIGN: A total of 351 patients undergoing surgery with an LMA will be included in this prospective, randomized, double-blind controlled, multicenter clinical trial. The patients will be randomly assigned to the three treatment arms: desflurane (n = 117), sevoflurane (n = 117), and propofol (n = 117). The emergence time (time to state the date of birth) will be the primary endpoint of this study. The secondary endpoints include further emergence times, such as time to open eyes, to remove LMA, to respond to command and to state name. Additionally, we will determine the frequency of cough and laryngospasm, measured intraoperatively and at emergence. We will assess the postoperative recovery on the first postoperative day via the Postoperative Quality Recovery Scale.
Despite increasing importance of cost-effective and safe anesthesia application, we lack proof for the most advantageous anesthetic agent, when an LMA is used. There are only a few RCTs comparing desflurane to other commonly used anesthetics (sevoflurane, propofol and isoflurane) in patients with LMA. These RCTs were conducted with small sample sizes, huge interstudy variability, and some also showed strong biases. The present multicenter RCT will provide results from a large sample size with a standardized study protocol and minimized bias, which is feasible in the clinical routine. Furthermore, we will expand our knowledge regarding the most favorable recovery on the first postoperative day, which impacts patients' comfort after surgery.
EudraCT Identifier: 2014-003810-96, 5 September 2014 ClinicalTrials.gov: NCT02322502, December 2014.
在合适的患者中使用喉罩气道（LMA）有助于实现快速麻醉，且术后气道相关不良事件的发生率较低。关于在此背景下最有利的麻醉药物，即上呼吸道并发症发生率最低且苏醒时间快的数据存在争议且有限。地氟醚似乎最符合这些标准，但缺乏采用标准化研究方案的大型随机对照试验（RCT）。因此，我们旨在通过一项有足够效力的RCT，比较地氟醚与其他常用麻醉药物七氟醚和丙泊酚。我们假设在地氟醚组上呼吸道事件的发生率不低于其他两组，且在苏醒时间方面优于七氟醚和丙泊酚组。
方法/设计：本前瞻性、随机、双盲对照、多中心临床试验将纳入总共351例使用LMA进行手术的患者。患者将被随机分配至三个治疗组：地氟醚组（n = 117）、七氟醚组（n = 117）和丙泊酚组（n = 117）。苏醒时间（说出出生日期的时间）将作为本研究的主要终点。次要终点包括进一步的苏醒时间，如睁眼时间、拔除LMA时间、对指令做出反应时间和说出姓名时间。此外，我们将确定术中及苏醒时咳嗽和喉痉挛的发生率。我们将通过术后质量恢复量表评估术后第一天的恢复情况。
尽管具有成本效益和安全的麻醉应用的重要性日益增加，但当使用LMA时，我们仍缺乏关于最有利麻醉药物的证据。仅有少数RCT在使用LMA的患者中比较了地氟醚与其他常用麻醉药物（七氟醚、丙泊酚和异氟醚）。这些RCT样本量小，研究间变异性大，且一些还存在严重偏倚。本多中心RCT将提供来自大样本量、采用标准化研究方案且偏倚最小的结果，这在临床常规中是可行的。此外，我们将扩展关于术后第一天最有利恢复情况的知识，这会影响患者术后的舒适度。
欧盟临床试验数据库标识符：2014 - 003810 - 96，2014年9月5日；美国国立医学图书馆临床试验注册中心：NCT02322502，2014年12月。
