A randomized, double-blind study to evaluate the efficacy and safety of three different doses of palonosetron versus placebo for preventing postoperative nausea and vomiting

Anesthesia and Analgesia

Volumn 107, Issue 2, 2008, Pages 445-451

  Candiotti, Keith A ^a   Kovac, Anthony L ^b   Melson, Timothy I ^c   Clerici, Giuseppina ^d,f   Joo Gan, Tong ^e  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF KANSAS SCHOOL OF MEDICINE   (United States)

^c Helen Keller Memorial Hospital   (United Kingdom)

^d HELSINN HEALTHCARE SA   (Switzerland)

^e DUKE UNIVERSITY MEDICAL CENTER   (United States)

^f PO Box 357 ^*  (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

BARBITURIC ACID DERIVATIVE; FENTANYL; METHOHEXITAL; MIDAZOLAM; PALONOSETRON; PLACEBO; PROPOFOL; ANTIEMETIC AGENT; ISOQUINOLINE DERIVATIVE; QUINUCLIDINE DERIVATIVE; SEROTONIN ANTAGONIST;

ABDOMINAL SURGERY; ADULT; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; FEMALE; GYNECOLOGIC SURGERY; HUMAN; LAPAROSCOPIC SURGERY; MAJOR CLINICAL STUDY; MALE; MOTION SICKNESS; OUTPATIENT; POSTOPERATIVE NAUSEA AND VOMITING; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SMOKING; ADOLESCENT; AGED; BREAST; MIDDLE AGED; MULTICENTER STUDY;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIEMETICS; BREAST; DOUBLE-BLIND METHOD; FEMALE; GYNECOLOGIC SURGICAL PROCEDURES; HUMANS; ISOQUINOLINES; MIDDLE AGED; POSTOPERATIVE NAUSEA AND VOMITING; QUINUCLIDINES; SEROTONIN ANTAGONISTS;

EID: 49949098505     PISSN: 00032999     EISSN: None     Source Type: Journal    
DOI: 10.1213/ane.0b013e31817b5ebb     Document Type: Article

References (19)

1. Gralla R, Lichinitser M, Van der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol 2003;14:1570-7
2. Decker GM, DeMeyer ES, Kisko DL. Measuring the maintenance of daily life activities using the functional living indexemesis (FLIE) in patients receiving moderately emetogenic chemotherapy. J Support Oncol 2006;4:35-41
3. Wong EHF, Clark R, Leung E, Loury D, Bonhaus DW, Jakeman L, Parnes H, Whiting RL, Eglen RM. The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol 1995;114:851-9
4. Miller RC, Galvan M, Gittos MW, van Giersbergen PLM, Moser PC, Fozard JR. Pharmacological properties of dolasetron, a potent and selective antagonist at 5-HT3 receptors. Drug Dev Res 1993;28:87-93
5. Gan TJ. Selective serotonin 5-HT3 receptor antagonists for postoperative nausea and vomiting. Are they all the same? CNS Drugs 2005;19:225-38
6. Stoltz R, Cyong J-C, Shah A, Parisi S. Pharmacokinetic and safety evaluation of palonosetron, a 5-hydroxytryptamine-3 receptor antagonist, in U.S. and Japanese healthy subjects. J Clin Pharmacol 2004;44:520 -31
7. Rojas C, Stathis M, Thomas AG, Massuda E, Alt J, Zhang J, Rubenstein E, Sebastiani S, Cantoreggi S, Snyder SH, Slusher B. Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor. Anesth Analg 2008;107:469-78
8. Eisenberg P, Figueroa-Vadillo J, Zamora R, Charu V, Hajdenberg J, Cartmell A, Macciocchi A, Grunberg S. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist. Cancer 2003;98:2473-82
9. Tang J, D'Angelo R, White PF, Scuderi PE. The efficacy of RS-25259, a long-acting selective 5-HT3 receptor antagonist, for preventing postoperative nausea and vomiting after hysterectomy procedures. Anesth Analg 1998;87:462-7
10. White PF, Scuderi P. Prevention of Postoperative Nausea and Vomiting (PONV): a dose-ranging study involving palonosetron, a potent 5-HT3 receptor antagonist. Anesthesiology 2005;103:A703
11. Osoba D, Zee B, Warr D, Kaizer L, Latreille J, Pater J. Quality of life studies in chemotherapy-induced emesis. Oncology 1996;53:92-5
12. Gupta A, Wu CL, Elkassabany N, Krug CE, Parker SD, Fleisher LA. Does the routine prophylactic use of antiemetics affect the incidence of postdischarge nausea and vomiting following ambulatory surgery? Anesthesiology 2003;99:488-95
13. Wu CL, Berenholtz SM, Pronovost PJ, Fleisher LA. Systemic review and analysis of postdischarge symptoms after outpatient surgery. Anesthesiology 2002;96:994-1003
14. Odom-Forren J, Fetzer SJ, Moser DK. Evidence-based interventions for post discharge nausea and vomiting: a review of the literature. J Perianesth Nurs 2006;21:411-30
15. Wright CD, Jilka J, Gentry WB. Efficacy of promethazine suppositories dispensed to outpatient surgical patients. Yale J Biol Med 1998;71:391-5
16. Parlow JL, Meikle AT, van Vlymen J, Avery N. Post discharge nausea and vomiting after ambulatory laparoscopy is not reduced by promethazine prophylaxis. Can J Anaesth 1999;46:719-24
17. White PF, Issioui T, Hu J, Jones SB, Coleman JE, Waddle JP, Markowitz SD, Coloma M, Macaluso AR. Comparative efficacy of acustimulation (ReliefBand®) versus ondansetron (Zofran®) in combination with droperidol for preventing nausea and vomiting. Anesthesiology 2002;97:1075-81
18. Gan TJ, Franiak R, Reeves J. Ondansetron orally disintegrating tablet versus placebo for the prevention of postdischarge nausea and vomiting after ambulatory surgery. Anest h Analg 2002;94:1199-1200
19. Kovac AL, Eberhart L, Kotarski J, Clerici G, Apfel CC, Palonosetron 04-07 Study Group. A randomized, double-blind study to evaluate the efficacy and safety of three different doses of palonosetron versus placebo in preventing postoperative nausea and vomiting over a 72-hour period. Anesth Analg 2008;107:439-44