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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Comparison of the effectiveness of low pressure pneumoperitoneum with profound muscle relaxation during laparoscopic donor nephrectomy to optimize the quality of recovery during the early post-operative phase: study protocol for a randomized controlled clinical trial

Authors: Denise M. D. Özdemir-van Brunschot, Gert J. Scheffer, Albert Dahan, Janneke E. E. A. Mulder, Simone A. A. Willems, Luuk B. Hilbrands, Frank C. H. d’Ancona, Rogier A. R. T. Donders, Kees J. H. M. van Laarhoven, Michiel C. Warlé

Published in: Trials | Issue 1/2015

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Abstract

Background

Since technique modifications of laparoscopic donor nephrectomy, e.g. retroperitoneoscopic donor nephrectomy or hand-assistance, have not shown significant benefit regarding safety or improvement of recovery, further research should focus on improving postoperative recovery. The use of low pressure pneumoperitoneum has shown to significantly reduce postoperative pain after laparoscopy. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block will be used.

Methods/Design

This trial is a phase IV, single center, double-blind, randomized controlled clinical trial in which 64 patients will be randomized to: low pressure pneumoperitoneum (6 mmHg) and deep neuromuscular block or normal pressure pneumoperitoneum (12 mmHg) and deep neuromuscular block. Deep neuromuscular block is defined as post tetanic count < 5. Primary outcome measurement will be Quality of Recovery-40 questionnaire (overall score) on day 1.

Discussion

This study is the first randomized study to assess the combination of low pressure pneumoperitoneum in combination with deep neuromuscular block from a patients’ perspective. The study findings may also be applicable for other laparoscopic procedures.

Trial registration

The trial was registered at trials.gov (NCT02146417) in July 2014.
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Metadata
Title
Comparison of the effectiveness of low pressure pneumoperitoneum with profound muscle relaxation during laparoscopic donor nephrectomy to optimize the quality of recovery during the early post-operative phase: study protocol for a randomized controlled clinical trial
Authors
Denise M. D. Özdemir-van Brunschot
Gert J. Scheffer
Albert Dahan
Janneke E. E. A. Mulder
Simone A. A. Willems
Luuk B. Hilbrands
Frank C. H. d’Ancona
Rogier A. R. T. Donders
Kees J. H. M. van Laarhoven
Michiel C. Warlé
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0887-7

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