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...
Autores principales: | , , , , , , , , , , , , , , , , , , |
---|---|
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 |