Cargando…

Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial

Postoperative nausea and vomiting (PONV) after vitreoretinal surgery may potentially be associated with severe complications, such as suprachoroidal hemorrhage. The purpose of the present multicenter clinical trial (NCT02386059) was to assess the efficacy of three different prophylactic treatments f...

Descripción completa

Detalles Bibliográficos
Autores principales: Reibaldi, Michele, Fallico, Matteo, Longo, Antonio, Avitabile, Teresio, Astuto, Marinella, Murabito, Paolo, Minardi, Carmelo, Bonfiglio, Vincenza, Boscia, Francesco, Furino, Claudio, Rejdak, Robert, Nowomiejska, Katarzyna, Toro, Mario, Cennamo, Gilda, Cillino, Salvatore, Rinaldi, Michele, Fiore, Tito, Cagini, Carlo, Russo, Andrea
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463101/
https://www.ncbi.nlm.nih.gov/pubmed/30901867
http://dx.doi.org/10.3390/jcm8030391
_version_ 1783410701610516480
author Reibaldi, Michele
Fallico, Matteo
Longo, Antonio
Avitabile, Teresio
Astuto, Marinella
Murabito, Paolo
Minardi, Carmelo
Bonfiglio, Vincenza
Boscia, Francesco
Furino, Claudio
Rejdak, Robert
Nowomiejska, Katarzyna
Toro, Mario
Cennamo, Gilda
Cillino, Salvatore
Rinaldi, Michele
Fiore, Tito
Cagini, Carlo
Russo, Andrea
author_facet Reibaldi, Michele
Fallico, Matteo
Longo, Antonio
Avitabile, Teresio
Astuto, Marinella
Murabito, Paolo
Minardi, Carmelo
Bonfiglio, Vincenza
Boscia, Francesco
Furino, Claudio
Rejdak, Robert
Nowomiejska, Katarzyna
Toro, Mario
Cennamo, Gilda
Cillino, Salvatore
Rinaldi, Michele
Fiore, Tito
Cagini, Carlo
Russo, Andrea
author_sort Reibaldi, Michele
collection PubMed
description Postoperative nausea and vomiting (PONV) after vitreoretinal surgery may potentially be associated with severe complications, such as suprachoroidal hemorrhage. The purpose of the present multicenter clinical trial (NCT02386059) was to assess the efficacy of three different prophylactic treatments for PONV after vitrectomy under local anesthesia. Patients undergoing primary vitrectomy were randomized to the control arm or to one of the treatment arms (4 mg ondansetron, 4 mg dexamethasone, combination of the two drugs). The primary outcome measure was the proportion of complete response (no nausea, no vomiting, no retching, and no use of antiemetic rescue medication) during 24 h after vitrectomy. Secondary outcomes included the severity standardized score of PONV, postoperative pain standardized score, and rate of ocular and non-ocular adverse events. Baseline demographics of the 1287 patients were comparable between the four arms. The combined therapy group showed a statistically significant lower incidence of PONV compared to the placebo and monotherapy (p < 0.001). PONV severity was also reduced in the combination group compared to the others (p < 0.001). Postoperative pain scores and adverse events were comparable among the four groups. Combined therapy with dexamethasone and ondansetron was the most effective treatment for reducing the incidence and severity of PONV in patients undergoing vitrectomy under local anesthesia.
format Online
Article
Text
id pubmed-6463101
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-64631012019-04-19 Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial Reibaldi, Michele Fallico, Matteo Longo, Antonio Avitabile, Teresio Astuto, Marinella Murabito, Paolo Minardi, Carmelo Bonfiglio, Vincenza Boscia, Francesco Furino, Claudio Rejdak, Robert Nowomiejska, Katarzyna Toro, Mario Cennamo, Gilda Cillino, Salvatore Rinaldi, Michele Fiore, Tito Cagini, Carlo Russo, Andrea J Clin Med Article Postoperative nausea and vomiting (PONV) after vitreoretinal surgery may potentially be associated with severe complications, such as suprachoroidal hemorrhage. The purpose of the present multicenter clinical trial (NCT02386059) was to assess the efficacy of three different prophylactic treatments for PONV after vitrectomy under local anesthesia. Patients undergoing primary vitrectomy were randomized to the control arm or to one of the treatment arms (4 mg ondansetron, 4 mg dexamethasone, combination of the two drugs). The primary outcome measure was the proportion of complete response (no nausea, no vomiting, no retching, and no use of antiemetic rescue medication) during 24 h after vitrectomy. Secondary outcomes included the severity standardized score of PONV, postoperative pain standardized score, and rate of ocular and non-ocular adverse events. Baseline demographics of the 1287 patients were comparable between the four arms. The combined therapy group showed a statistically significant lower incidence of PONV compared to the placebo and monotherapy (p < 0.001). PONV severity was also reduced in the combination group compared to the others (p < 0.001). Postoperative pain scores and adverse events were comparable among the four groups. Combined therapy with dexamethasone and ondansetron was the most effective treatment for reducing the incidence and severity of PONV in patients undergoing vitrectomy under local anesthesia. MDPI 2019-03-21 /pmc/articles/PMC6463101/ /pubmed/30901867 http://dx.doi.org/10.3390/jcm8030391 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Reibaldi, Michele
Fallico, Matteo
Longo, Antonio
Avitabile, Teresio
Astuto, Marinella
Murabito, Paolo
Minardi, Carmelo
Bonfiglio, Vincenza
Boscia, Francesco
Furino, Claudio
Rejdak, Robert
Nowomiejska, Katarzyna
Toro, Mario
Cennamo, Gilda
Cillino, Salvatore
Rinaldi, Michele
Fiore, Tito
Cagini, Carlo
Russo, Andrea
Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial
title Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial
title_full Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial
title_fullStr Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial
title_full_unstemmed Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial
title_short Efficacy of Three Different Prophylactic Treatments for Postoperative Nausea and Vomiting after Vitrectomy: A Randomized Clinical Trial
title_sort efficacy of three different prophylactic treatments for postoperative nausea and vomiting after vitrectomy: a randomized clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463101/
https://www.ncbi.nlm.nih.gov/pubmed/30901867
http://dx.doi.org/10.3390/jcm8030391
work_keys_str_mv AT reibaldimichele efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT fallicomatteo efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT longoantonio efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT avitabileteresio efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT astutomarinella efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT murabitopaolo efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT minardicarmelo efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT bonfigliovincenza efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT bosciafrancesco efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT furinoclaudio efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT rejdakrobert efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT nowomiejskakatarzyna efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT toromario efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT cennamogilda efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT cillinosalvatore efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT rinaldimichele efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT fioretito efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT caginicarlo efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial
AT russoandrea efficacyofthreedifferentprophylactictreatmentsforpostoperativenauseaandvomitingaftervitrectomyarandomizedclinicaltrial