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Randomized Controlled Trial Multicenter Study Comparative Study
Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study.
- Bruintjes Moira H D MH Department of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The, Andries E Braat, Albert Dahan, Gert-Jan Scheffer, Luuk B Hilbrands, Frank C H d'Ancona, Rogier A R T Donders, Cornelis J H M van Laarhoven, and Michiel C Warlé.
- Department of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands. Moira.Bruintjes@radboudumc.nl.
- Trials. 2017 Mar 4; 18 (1): 99.
BackgroundPostoperative 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.MethodsThe 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.DiscussionThis 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.Trial Registrationclinicaltrials.gov, NCT02838134 . Registered on 29 June 2016.
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