title: A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period.
abstract: OBJECTIVE
  We performed a multicenter, randomized, double-blind trial to assess the efficacy and safety of a single, fixed, intravenous dose of palonosetron (0.075 mg) in the treatment of established postoperative nausea and vomiting (PONV).
  
  
  METHODS
  Three hundred and eighty-four patients who had at least one risk factors of PONV and underwent surgery under general anesthesia were screened. Those who developed PONV were randomized to receive either 0.075 mg intravenous palonosetron or a placebo. The incidence of nausea and vomiting, severity of nausea, requirements for rescue anti-emetics, and adverse effects at 2, 24, and 72 h after drug administration were evaluated. Complete response (CR) and complete control (CC) rate were compared for 24 and 72 h.
  
  
  RESULTS
  Among the 384 patients, 152 (39.6 %) developed PONV and were randomized to either the palonosetron (n = 75) or placebo (n = 77) group. The number of patients with CR at 24 and 72 h was higher in the palonosetron group than the placebo group [0-24 h: n = 49 (68.1 %) vs. n = 30 (40.5 %), p < 0.001; 0-72 h: n = 47 (65.3 %) vs. n = 28 (37.8 %), p < 0.001]. The incidence of PONV at 2, 24, and 72 h periods was lower in the palonosetron group than the placebo group (29.2, 45.8, and 50.0 % in the palonosetron group vs. 50.0, 62.2, and 66.2 % in the placebo group, p = 0.010, 0.048, 0.047, respectively). The incidence of adverse events was not different between the groups.
  
  
  CONCLUSIONS
  A single 0.075 mg IV dose of palonosetron effectively increased the CR rates at 24 and 72 h in these moderate-risk patients with established PONV.
authors.affiliation: Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Tae Soo
authors.initials: TS
authors.lastname: Hahm
authors.forename: Jung Won
authors.initials: JW
authors.lastname: Hwang
authors.forename: Won Ho
authors.initials: WH
authors.lastname: Kim
authors.forename: Eun Jung
authors.initials: EJ
authors.lastname: Oh
authors.forename: Duk-Kyung
authors.initials: DK
authors.lastname: Kim
authors.forename: Won Joon
authors.initials: WJ
authors.lastname: Choi
authors.forename: Yun Hong
authors.initials: YH
authors.lastname: Kim
authors.forename: Jung Hee
authors.initials: JH
authors.lastname: Ryu
authors.forename: Byung Hoon
authors.initials: BH
authors.lastname: Yoo
authors.forename: Jun Heum
authors.initials: JH
authors.lastname: Yon
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000768:Anesthesia, General / Q000379:methods; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D007546:Isoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000077924:Palonosetron; D020250:Postoperative Nausea and Vomiting / Q000188:drug therapy* / Q000453:epidemiology; D011446:Prospective Studies; D011812:Quinuclidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D011812:Quinuclidines; D000077924:Palonosetron