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Trials
2017 Mar 04;181:99. doi: 10.1186/s13063-017-1785-y.
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Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study.
Bruintjes MH
,
Braat AE
,
Dahan A
,
Scheffer GJ
,
Hilbrands LB
,
d'Ancona FC
,
Donders RA
,
van Laarhoven CJ
,
Warlé MC
.
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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.
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