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A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron

BACKGROUND: Craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy i...

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Autores principales: Ryu, Jung-Hee, Lee, Ji-Eun, Lim, Young-Jin, Hong, Deok-Man, Park, Hee-Pyoung, Han, Jong-In, Baik, Hee-Jung, Kim, Hyun-Zu, Min, Kyeong-Tae, Do, Sang-Hwan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4124476/
https://www.ncbi.nlm.nih.gov/pubmed/25104916
http://dx.doi.org/10.1186/1471-2253-14-63
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author Ryu, Jung-Hee
Lee, Ji-Eun
Lim, Young-Jin
Hong, Deok-Man
Park, Hee-Pyoung
Han, Jong-In
Baik, Hee-Jung
Kim, Hyun-Zu
Min, Kyeong-Tae
Do, Sang-Hwan
author_facet Ryu, Jung-Hee
Lee, Ji-Eun
Lim, Young-Jin
Hong, Deok-Man
Park, Hee-Pyoung
Han, Jong-In
Baik, Hee-Jung
Kim, Hyun-Zu
Min, Kyeong-Tae
Do, Sang-Hwan
author_sort Ryu, Jung-Hee
collection PubMed
description BACKGROUND: Craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients. METHODS: A total of 160 American Society of Anesthesiologists physical status I–II patients aged 19–65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study. All patients received total intravenous anesthesia (TIVA) with propofol and remifentanil. Patients were randomly allocated into three groups to receive ondansetron (4 mg; group A, n  =  55), ondansetron (8 mg; group B, n  =  54), or ramosetron (0.3 mg; group C, n  =  51) intravenously at the time of dural closure. The incidence of PONV, the need for rescue antiemetics, pain score, patient-controlled analgesia (PCA) consumption, and adverse events were recorded 48 h postoperatively. RESULTS: Among the initial 160 patients, 127 completed the study and were included in the final analysis. The incidences of PONV were lower (nausea, 14% vs. 59% and 41%, respectively; P  <  0.001; vomiting, P  =  0.048) and the incidence of complete response was higher (83% vs. 37% and 59%, respectively; P  <  0.001) in group C than in groups A and B at 48 h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0–2 h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2–48 h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events. CONCLUSION: Intravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients. Ramosetron at 0.3 mg was more effective than ondansetron at 4 or 8 mg for preventing PONV in adult craniotomy patients. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) Identifier: KCT0000320. Registered 9 January 2012.
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spelling pubmed-41244762014-08-08 A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron Ryu, Jung-Hee Lee, Ji-Eun Lim, Young-Jin Hong, Deok-Man Park, Hee-Pyoung Han, Jong-In Baik, Hee-Jung Kim, Hyun-Zu Min, Kyeong-Tae Do, Sang-Hwan BMC Anesthesiol Research Article BACKGROUND: Craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients. METHODS: A total of 160 American Society of Anesthesiologists physical status I–II patients aged 19–65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study. All patients received total intravenous anesthesia (TIVA) with propofol and remifentanil. Patients were randomly allocated into three groups to receive ondansetron (4 mg; group A, n  =  55), ondansetron (8 mg; group B, n  =  54), or ramosetron (0.3 mg; group C, n  =  51) intravenously at the time of dural closure. The incidence of PONV, the need for rescue antiemetics, pain score, patient-controlled analgesia (PCA) consumption, and adverse events were recorded 48 h postoperatively. RESULTS: Among the initial 160 patients, 127 completed the study and were included in the final analysis. The incidences of PONV were lower (nausea, 14% vs. 59% and 41%, respectively; P  <  0.001; vomiting, P  =  0.048) and the incidence of complete response was higher (83% vs. 37% and 59%, respectively; P  <  0.001) in group C than in groups A and B at 48 h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0–2 h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2–48 h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events. CONCLUSION: Intravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients. Ramosetron at 0.3 mg was more effective than ondansetron at 4 or 8 mg for preventing PONV in adult craniotomy patients. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) Identifier: KCT0000320. Registered 9 January 2012. BioMed Central 2014-08-04 /pmc/articles/PMC4124476/ /pubmed/25104916 http://dx.doi.org/10.1186/1471-2253-14-63 Text en Copyright © 2014 Ryu et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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 Research Article
Ryu, Jung-Hee
Lee, Ji-Eun
Lim, Young-Jin
Hong, Deok-Man
Park, Hee-Pyoung
Han, Jong-In
Baik, Hee-Jung
Kim, Hyun-Zu
Min, Kyeong-Tae
Do, Sang-Hwan
A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron
title A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron
title_full A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron
title_fullStr A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron
title_full_unstemmed A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron
title_short A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron
title_sort prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (ponv) after craniotomy: comparison with ondansetron
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4124476/
https://www.ncbi.nlm.nih.gov/pubmed/25104916
http://dx.doi.org/10.1186/1471-2253-14-63
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