Bruintjes Moira H D, Braat Andries E, Dahan Albert, Scheffer Gert-Jan, Hilbrands Luuk B, d'Ancona Frank C H, Donders Rogier A R T, van Laarhoven Cornelis J H M, Warlé Michiel C
Department of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands.
Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Trials. 2017 Mar 4;18(1):99. doi: 10.1186/s13063-017-1785-y.
Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce postoperative pain scores after laparoscopic surgery. In this study, we will investigate whether deep neuromuscular blockade also improves the early quality of recovery after live donor nephrectomy.
The RELAX-study is a phase IV, multicenter, double-blinded, randomized controlled trial, in which 96 patients, scheduled for living donor nephrectomy, will be randomized into two groups: one with deep and one with moderate neuromuscular blockade. Deep neuromuscular blockade is defined as a post-tetanic count of 1-2. Our primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 24 h after extubation.
This study is, to our knowledge, the first randomized study to assess the effectiveness of deep neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. The study findings may also be applicable for other laparoscopic procedures.
clinicaltrials.gov, NCT02838134 . Registered on 29 June 2016.
活体供肾肾切除术后的恢复很大程度上取决于术后疼痛和镇痛药物使用的后果。已表明使用深度神经肌肉阻滞可降低腹腔镜手术后的术后疼痛评分。在本研究中，我们将调查深度神经肌肉阻滞是否也能改善活体供肾肾切除术后的早期恢复质量。
RELAX研究是一项IV期、多中心、双盲、随机对照试验，其中96例计划进行活体供肾肾切除术的患者将被随机分为两组：一组采用深度神经肌肉阻滞，另一组采用中度神经肌肉阻滞。深度神经肌肉阻滞定义为强直后计数为1-2。我们的主要结局指标将是拔管后24小时的恢复质量-40问卷（总分）。
据我们所知，本研究是第一项评估腹腔镜供肾肾切除术中深度神经肌肉阻滞对促进术后恢复有效性的随机研究。研究结果也可能适用于其他腹腔镜手术。
clinicaltrials.gov，NCT02838134。于2016年6月29日注册。
