Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study

Trials. 2017 Mar 4;18(1):99. doi: 10.1186/s13063-017-1785-y.

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: clinicaltrials.gov, NCT02838134 . Registered on 29 June 2016.

Keywords: Deep neuromuscular block; Early quality of recovery; Laparoscopic donor nephrectomy; Randomized controlled trial; Rocuronium.

Publication types

  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Protocols
  • Comparative Effectiveness Research
  • Double-Blind Method
  • Humans
  • Kidney Transplantation / adverse effects
  • Kidney Transplantation / methods*
  • Laparoscopy / adverse effects
  • Laparoscopy / methods*
  • Living Donors*
  • Muscle Relaxation / drug effects*
  • Nephrectomy / adverse effects
  • Nephrectomy / methods*
  • Netherlands
  • Neuromuscular Agents / administration & dosage*
  • Neuromuscular Agents / adverse effects
  • Neuromuscular Blockade / adverse effects
  • Neuromuscular Blockade / methods*
  • Pain Measurement
  • Pain, Postoperative / etiology
  • Pain, Postoperative / prevention & control
  • Quality of Life
  • Recovery of Function
  • Research Design
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Substances

  • Neuromuscular Agents

Associated data

  • ClinicalTrials.gov/NCT02838134