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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Published in: Trials 1/2019

Open Access 01-12-2019 | Obesity | Study protocol

Intraoperative immunomodulatory effects of sevoflurane versus total intravenous anesthesia with propofol in bariatric surgery (the OBESITA trial): study protocol for a randomized controlled pilot trial

Authors: Giselle Carvalho de Sousa, Fernanda Ferreira Cruz, Luciana Boavista Heil, Carlos José Saboya Sobrinho, Felipe Saddy, Frederico Paranhos Knibel, Joana Barreto Pereira, Marcus J. Schultz, Paolo Pelosi, Marcelo Gama de Abreu, Pedro Leme Silva, Patricia Rieken Macedo Rocco

Published in: Trials | Issue 1/2019

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Abstract

Background

Obesity is associated with a chronic systemic inflammatory process. Volatile or intravenous anesthetic agents may modulate immune function, and may do so differentially in obesity. However, no study has evaluated whether these potential immunomodulatory effects differ according to type of anesthesia in obese patients undergoing laparoscopic bariatric surgery.

Methods/design

The OBESITA trial is a prospective, nonblinded, single-center, randomized, controlled clinical pilot trial. The trial will include 48 patients with a body mass index ≥ 35 kg/m2, scheduled for laparoscopic bariatric surgery using sleeve or a Roux-en-Y gastric bypass technique, who will be allocated 1:1 to undergo general inhalational anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol. The primary endpoint is the difference in plasma interleukin (IL)-6 levels when comparing the two anesthetic agents. Blood samples will be collected prior to anesthesia induction (baseline), immediately after anesthetic induction, and before endotracheal extubation. Levels of other proinflammatory and anti-inflammatory cytokines, neutrophil chemotaxis, macrophage differentiation, phagocytosis, and occurrence of intraoperative and postoperative complications will also be evaluated.

Discussion

To our knowledge, this is the first randomized clinical trial designed to compare the effects of two different anesthetics on immunomodulation in obese patients undergoing laparoscopic bariatric surgery. Our hypothesis is that anesthesia with sevoflurane will result in a weaker proinflammatory response compared to anesthesia with propofol, with lower circulating levels of IL-6 and other proinflammatory mediators, and increased macrophage differentiation into the M2 phenotype in adipose tissue.

Trial registration

Registro Brasileiro de Ensaios Clínicos, RBR-77kfj5. Registered on 25 July 2018.
Appendix
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Metadata
Title
Intraoperative immunomodulatory effects of sevoflurane versus total intravenous anesthesia with propofol in bariatric surgery (the OBESITA trial): study protocol for a randomized controlled pilot trial
Authors
Giselle Carvalho de Sousa
Fernanda Ferreira Cruz
Luciana Boavista Heil
Carlos José Saboya Sobrinho
Felipe Saddy
Frederico Paranhos Knibel
Joana Barreto Pereira
Marcus J. Schultz
Paolo Pelosi
Marcelo Gama de Abreu
Pedro Leme Silva
Patricia Rieken Macedo Rocco
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3399-z

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