title: Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study.
abstract: 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.
authors.affiliation: 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.
authors.forename: Moira H D
authors.initials: MH
authors.lastname: Bruintjes
authors.affiliation: Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
authors.forename: Andries E
authors.initials: AE
authors.lastname: Braat
authors.affiliation: Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
authors.forename: Albert
authors.initials: A
authors.lastname: Dahan
authors.affiliation: Department of Anesthesiology, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands.
authors.forename: Gert-Jan
authors.initials: GJ
authors.lastname: Scheffer
authors.affiliation: Department of Nephrology, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands.
authors.forename: Luuk B
authors.initials: LB
authors.lastname: Hilbrands
authors.affiliation: Department of Urology, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands.
authors.forename: Frank C H
authors.initials: FC
authors.lastname: d'Ancona
authors.affiliation: Department for Health Evidence, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands.
authors.forename: Rogier A R T
authors.initials: RA
authors.lastname: Donders
authors.affiliation: Department of Surgery, Division of General Surgery, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands.
authors.forename: Cornelis J H M
authors.initials: CJ
authors.lastname: van Laarhoven
authors.affiliation: Department of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein 10, 6525 GA, Nijmegen, The Netherlands.
authors.forename: Michiel C
authors.initials: MC
authors.lastname: Warlé
mesh_terms: D002985:Clinical Protocols; D057186:Comparative Effectiveness Research; D004311:Double-Blind Method; D006801:Humans; D016030:Kidney Transplantation / Q000009:adverse effects / Q000379:methods*; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D019520:Living Donors; D009126:Muscle Relaxation / Q000187:drug effects*; D009392:Nephrectomy / Q000009:adverse effects / Q000379:methods*; D009426:Netherlands; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019148:Neuromuscular Blockade / Q000009:adverse effects / Q000379:methods*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents
keywords: Deep neuromuscular block; Early quality of recovery; Laparoscopic donor nephrectomy; Randomized controlled trial; Rocuronium