title: A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  CLINICAL RESEARCH INFORMATION SERVICE (CRIS) IDENTIFIER: KCT0000320. Registered 9 January 2012.
authors.affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, South Korea ; Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea.
authors.forename: Jung-Hee
authors.initials: JH
authors.lastname: Ryu
authors.affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea.
authors.forename: Ji-Eun
authors.initials: JE
authors.lastname: Lee
authors.affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea ; Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea.
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Lim
authors.affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea ; Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea.
authors.forename: Deok-Man
authors.initials: DM
authors.lastname: Hong
authors.affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea ; Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea.
authors.forename: Hee-Pyoung
authors.initials: HP
authors.lastname: Park
authors.affiliation: Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Jong-In
authors.initials: JI
authors.lastname: Han
authors.affiliation: Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Hee-Jung
authors.initials: HJ
authors.lastname: Baik
authors.affiliation: Department of Anesthesiology and Pain Medicine, Severance Hospital, Seoul, South Korea.
authors.forename: Hyun-Zu
authors.initials: HZ
authors.lastname: Kim
authors.affiliation: Department of Anesthesiology and Pain Medicine, Severance Hospital, Seoul, South Korea.
authors.forename: Kyeong-Tae
authors.initials: KT
authors.lastname: Min
authors.affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, South Korea ; Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, Seoul, South Korea.
authors.forename: Sang-Hwan
authors.initials: SH
authors.lastname: Do
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D003399:Craniotomy / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000009:adverse effects / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000453:epidemiology; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000932:Antiemetics; D001562:Benzimidazoles; D017294:Ondansetron; C071315:ramosetron
keywords: Craniotomy; Ondansetron; Postoperative nausea and vomiting; Ramosetron
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