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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

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 inv...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5336688/
https://www.ncbi.nlm.nih.gov/pubmed/28259181
http://dx.doi.org/10.1186/s13063-017-1785-y
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author 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.
author_facet 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.
author_sort Bruintjes, Moira H. D.
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1785-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-53366882017-03-07 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. 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. Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1785-y) contains supplementary material, which is available to authorized users. BioMed Central 2017-03-04 /pmc/articles/PMC5336688/ /pubmed/28259181 http://dx.doi.org/10.1186/s13063-017-1785-y Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
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.
Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study
title Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study
title_full Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study
title_fullStr Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study
title_full_unstemmed Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study
title_short Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study
title_sort effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5336688/
https://www.ncbi.nlm.nih.gov/pubmed/28259181
http://dx.doi.org/10.1186/s13063-017-1785-y
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