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Titolo:
Pooled analysis of three large clinical trials to determine the optimal dose of dolasetron mesylate needed to prevent postoperative nausea and vomiting
Autore:
Philip, BK; McLeskey, CH; Chelly, JE; McKenzie, R; Kovac, AL; Diemunsch, P; DuBois, DM;
Indirizzi:
Brigham & Womens Hosp, Dept Anesthesiol Perioperat & Pain Med, Boston, MA 02115 USA Brigham & Womens Hosp Boston MA USA 02115 Pain Med, Boston, MA 02115 USA
Titolo Testata:
JOURNAL OF CLINICAL ANESTHESIA
fascicolo: 1, volume: 12, anno: 2000,
pagine: 1 - 8
SICI:
0952-8180(200002)12:1<1:PAOTLC>2.0.ZU;2-#
Fonte:
ISI
Lingua:
ENG
Soggetto:
INTRAVENOUS DOLASETRON; GYNECOLOGIC SURGERY; DOUBLE-BLIND; MULTICENTER; GRANISETRON; ONDANSETRON; MESILATE; LAPAROSCOPY; ANTAGONIST; EFFICACY;
Keywords:
antagonists, serotonin; antiemetics : administration, dosage; complications, postoperative; dolasetron mesylate; double-blind method, human; nausea and vomiting, postoperative;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
27
Recensione:
Indirizzi per estratti:
Indirizzo: Philip, BK Brigham & Womens Hosp, Dept Anesthesiol Perioperat & Pain Med, 75 Francis St, Boston, MA 02115 USA Brigham & Womens Hosp 75 Francis St Boston MA USA 02115 115 USA
Citazione:
B.K. Philip et al., "Pooled analysis of three large clinical trials to determine the optimal dose of dolasetron mesylate needed to prevent postoperative nausea and vomiting", J CLIN ANES, 12(1), 2000, pp. 1-8

Abstract

Study Objective: To identify the maximally effective dolasetron dose (ie.,maximun efficacy with minimum adverse events) for prevention of postoperative nausea and vomiting (PONV) using the statistical power generated in a pooled patient sample from three large nearly identical clinical trials. Design: Three randomized, multicenter, placebo-controlled, double-blinded trials. Setting: Trials 1, 2, and 3 enrolled patients at 10, 25, and 17 hospitals and/or surgical centers respectively. Patients: A total of 1,946 ASA physical status I, II, and III patients. Trials 1 and 2 enrolled only female patients (n = 916) undergoing gynecologicsurgery. Trials three enrolled 722 females (similar to 70% gynecologic surgeries and 308 males (similar to 46% orthopedic surgeries) undergoing a variety of surgical procedures. Interventions: All surgical procedures used balanced general anesthesia. Patients received 12.5, 25, 50, or 100 mg of the antiemetic, dolasetron, near the end of anesthesia. Measurements and Main Results: Efficacy endpoints were identical and measured for 24 hours: complete response (no vomiting or rescue medication) and maximum nausea, reported using a 100-mm visual analog scale (VAS). Safety was assessed using adverse event reports, laboratory and electrocardiographic data and visual signs. All four dolasetron doses produced significant increases in complete response and decreases in maximum VAS nausea compared with placebo (p < 0.01). No increased efficacy was observed with dolasetron doses higher than 12.5 mg. Safety was similar between each dolasetron dose and placebo. Conclusion: Dolasetron 12.5 mg, given near the end of anesthesia, is the,maximally effective dose studied for preventing postoperative nausea and vomiting. (C) 2000 by Elsevier Science Inc.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/09/20 alle ore 13:42:16