Brueckmann B, Sasaki N, Grobara P, Li M K, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri A S, McGovern F, Staehr-Rye A K, Eikermann M
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA.
Biostatistics and Research Decision Sciences, MSD, Oss, The Netherlands.
Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.
This study aimed to investigate whether reversal of rocuronium-induced neuromuscular blockade with sugammadex reduced the incidence of residual blockade and facilitated operating room discharge readiness.
Adult patients undergoing abdominal surgery received rocuronium, followed by randomized allocation to sugammadex (2 or 4 mg kg(-1)) or usual care (neostigmine/glycopyrrolate, dosing per usual care practice) for reversal of neuromuscular blockade. Timing of reversal agent administration was based on the providers' clinical judgement. Primary endpoint was the presence of residual neuromuscular blockade at PACU admission, defined as a train-of-four (TOF) ratio <0.9, using TOF-Watch® SX. Key secondary endpoint was time between reversal agent administration and operating room discharge-readiness; analysed with analysis of covariance.
Of 154 patients randomized, 150 had a TOF value measured at PACU entry. Zero out of 74 sugammadex patients and 33 out of 76 (43.4%) usual care patients had TOF-Watch SX-assessed residual neuromuscular blockade at PACU admission (odds ratio 0.0, 95% CI [0-0.06], P<0.0001). Of these 33 usual care patients, 2 also had clinical evidence of partial paralysis. Time between reversal agent administration and operating room discharge-readiness was shorter for sugammadex vs usual care (14.7 vs. 18.6 min respectively; P=0.02).
After abdominal surgery, sugammadex reversal eliminated residual neuromuscular blockade in the PACU, and shortened the time from start of study medication administration to the time the patient was ready for discharge from the operating room.
Clinicaltrials.gov:NCT01479764.
本研究旨在调查使用舒更葡糖逆转罗库溴铵诱导的神经肌肉阻滞是否能降低残余阻滞的发生率,并促进患者从手术室顺利出院。
接受腹部手术的成年患者先接受罗库溴铵,随后随机分配接受舒更葡糖(2或4 mg·kg⁻¹)或常规治疗(新斯的明/格隆溴铵,按常规治疗方法给药)以逆转神经肌肉阻滞。逆转剂的给药时间基于医护人员的临床判断。主要终点是在麻醉后监护病房(PACU)入院时存在残余神经肌肉阻滞,使用TOF-Watch® SX将其定义为四个成串刺激(TOF)比值<0.9。关键次要终点是从给予逆转剂到患者准备好从手术室出院的时间;采用协方差分析。
在154例随机分组的患者中,有150例在PACU入院时测量了TOF值。74例舒更葡糖治疗的患者中,0例在PACU入院时存在TOF-Watch SX评估的残余神经肌肉阻滞,而76例常规治疗的患者中有33例(43.4%)存在残余神经肌肉阻滞(优势比0.0,95%置信区间[0 - 0.06],P<0.0001)。在这33例常规治疗的患者中,有2例也有部分麻痹的临床证据。舒更葡糖组从给予逆转剂到患者准备好从手术室出院的时间比常规治疗组短(分别为14.7分钟和18.6分钟;P = 0.02)。
腹部手术后,舒更葡糖逆转可消除PACU中的残余神经肌肉阻滞,并缩短从开始研究用药到患者准备好从手术室出院的时间。
Clinicaltrials.gov:NCT01479764