Hostname: page-component-78c5997874-lj6df Total loading time: 0 Render date: 2024-11-02T20:46:08.307Z Has data issue: false hasContentIssue false
  • English
  • Français

Preoperatively administered ramosetron oral disintegrating tablets for preventing nausea and vomiting associated with patient-controlled analgesia in breast cancer patients

Published online by Cambridge University Press:  01 September 2008

H.-J. Lee ,
J.-Y. Kwon ,
S.-W. Shin ,
C.-H. Kim ,
S.-H. Baek ,
S.-W. Baik ,
H.-K. Kim  and
K.-H. Kim
H.-J. Lee
Affiliation:
Pusan National University, Medical Research Institute, School of Medicine, Department of Anesthesia and Pain Medicine, Busan, Republic of Korea
J.-Y. Kwon*
Affiliation:
Pusan National University, Medical Research Institute, School of Medicine, Department of Anesthesia and Pain Medicine, Busan, Republic of Korea
S.-W. Shin
Affiliation:
Pusan National University, Medical Research Institute, School of Medicine, Department of Anesthesia and Pain Medicine, Busan, Republic of Korea
C.-H. Kim
Affiliation:
Pusan National University, School of Dentistry, Department of Dental Anesthesia and Pain Medicine, Busan, Republic of Korea
S.-H. Baek
Affiliation:
Pusan National University, Medical Research Institute, School of Medicine, Department of Anesthesia and Pain Medicine, Busan, Republic of Korea
S.-W. Baik
Affiliation:
Pusan National University, Medical Research Institute, School of Medicine, Department of Anesthesia and Pain Medicine, Busan, Republic of Korea
H.-K. Kim
Affiliation:
Pusan National University, Medical Research Institute, School of Medicine, Department of Anesthesia and Pain Medicine, Busan, Republic of Korea
K.-H. Kim
Affiliation:
Pusan National University, Medical Research Institute, School of Medicine, Department of Anesthesia and Pain Medicine, Busan, Republic of Korea
*
Correspondence to: Jae-Young Kwon, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University, 1-10, Ami-dong, Seo-gu, Busan, 602-739, Republic of Korea. E-mail: [email protected]; Tel: +82 51 240 7399; Fax: +82 51 242 7466
Get access

Summary

Background and objectives

The purpose of this study was to investigate the acceptability and therapeutic efficacy of a preoperative single administration of long-acting 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist in an orally disintegrating tablet formulation, ramosetron, in breast cancer patients.

Methods

Two hundred and forty women, ASA I-II, aged 24–60 yr, undergoing elective breast cancer surgery, were randomized. A standardized anaesthetic technique was used. Patients were assigned to receive one of three treatment regimens (n = 80 in each group): no prophylactic antiemetics (Group A), single prophylactic intravenous injection of ramosetron 0.1 mg at the completion of surgery (Group B) or preoperatively oral administration of 0.1 mg of ramosetron (Group C). Episodes of nausea and vomiting, the use of rescue antiemetic treatment, degree of pain, adverse events and level of satisfaction were recorded.

Results

The overall incidence of nausea and vomiting during the first 24 h after the recovery in Groups B (27.8%) and C (25%) was decreased significantly compared with Group A (75.3%). The frequency of the use of rescue antiemetics was significantly lower in Group C (5.0%) compared with Groups A (53.2%) and B (15.2%). The patients in Group C were more satisfied with control of postoperative nausea and vomiting than others.

Conclusion

Preoperative oral administration of ramosetron at a dose of 0.1 mg is an acceptable and effective way of reducing the incidence of postoperative nausea and vomiting in breast cancer patients.

Keywords

BREAST SURGERYORAL ADMINISTRATIONPOSTOPERATIVE NAUSEA AND VOMITINGPREMEDICATIONRAMOSETRON
Type
Original Article
Information
European Journal of Anaesthesiology , Volume 25 , Issue 9 , September 2008 , pp. 756 - 762
Copyright
Copyright © European Society of Anaesthesiology 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Cohen, MM, Duncan, PG, DeBoer, DP et al. The postoperative interview: assessing risk factors for nausea and vomiting. Anesth Analg 1994; 78: 7–16.CrossRefGoogle ScholarPubMed
2.Gan, TJ, Ginsberg, B, Grant, AP et al. Double-blind, randomized comparison of ondansetron and intraoperative propofol to prevent postoperative nausea and vomiting. Anesthesiology 1996; 85: 1036–1042.CrossRefGoogle ScholarPubMed
3.Sadhasivam, S, Saxena, A, Kathirvel, S et al. The safety and efficacy of prophylactic ondansetron in patients undergoing modified radical mastectomy. Anesth Analg 1999; 89: 1340–1345.CrossRefGoogle ScholarPubMed
4.White, LA, Vanarase, M, Brockbank, K et al. Patient-controlled analgesia and postoperative nausea and vomiting: efficacy of a continuous infusion of ondansetron. Anaesthesia 2001; 56: 365–369.CrossRefGoogle ScholarPubMed
5.Walder, AD, Aitkenhead, AR. Antiemetic efficacy of metoclopramide when included in a patient-controlled analgesia infusion. Anaesthesia 1994; 49: 804–806.CrossRefGoogle Scholar
6.Alexander, R, Lovell, AT, Seingry, D et al. Comparison of ondansetron and droperidol in reducing postoperative nausea and vomiting associated with patient-controlled analgesia. Anaesthesia 1995; 50: 1086–1088.CrossRefGoogle ScholarPubMed
7.Dresner, M, Dean, S, Lumb, A et al. High-dose ondansetron regimen vs droperidol for morphine patient-controlled analgesia. Br J Anaesth 1998; 81: 384–386.CrossRefGoogle ScholarPubMed
8.Gombar, S, Kaur, J, Kumar Gombar, K et al. Superior anti-emetic efficacy of granisetron-dexamethasone combination in children undergoing middle ear surgery. Acta Anaesthesiol Scand 2007; 51: 621–624.CrossRefGoogle ScholarPubMed
9.Paech, MJ, Rucklidge, MW, Lain, J et al. Ondansetron and dexamethasone dose combinations for prophylaxis against postoperative nausea and vomiting. Anesth Analg 2007; 104: 808–814.CrossRefGoogle ScholarPubMed
10.Hartsell, T, Long, D, Kirsch, JR. The efficacy of postoperative ondansetron (Zofran) orally disintegrating tablets for preventing nausea and vomiting after acoustic neuroma surgery. Anesth Analg 2005; 101: 1492–1496.CrossRefGoogle ScholarPubMed
11.Cohen, IT, Joffe, D, Hummer, K et al. Ondansetron oral disintegrating tablets: acceptability and efficacy in children undergoing adenotonsillectomy. Anesth Analg 2005; 101: 59–63.CrossRefGoogle Scholar
12.Fujii, Y, Tanaka, H, Kawasaki, T. Preoperative oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery. Eur J Surg 2001; 167: 184–187.Google Scholar
13.Jokela, R, Koivuranta, M, Kangas-Saarela, T et al. Oral ondansetron, tropisetron or metoclopramide to prevent postoperative nausea and vomiting: a comparison in high-risk patients undergoing thyroid or parathyroid surgery. Acta Anaesthesiol Scand 2002; 46: 519–524.CrossRefGoogle Scholar
14.Hirata, T, Keto, Y, Funatsu, T et al. Evaluation of the pharmacological profile of ramosetron, a novel therapeutic agent for irritable bowel syndrome. J Pharmacol Sci 2007; 104: 263–273.CrossRefGoogle ScholarPubMed
15.Noda, K, Ikeda, M, Yoshida, O et al. Clinical evaluation of ramosetron injections in the treatment of cisplatin-induced nausea and vomiting. J Int Med Res 2002; 30: 211–219.CrossRefGoogle ScholarPubMed
16.Bland, JM, Altman, DG. Multiple significance tests: the Bonferroni method. BMJ 1995; 310: 170.CrossRefGoogle ScholarPubMed
17.Cohen, J. A Power Primer. Psychol Bull 1992; 112: 155–159.CrossRefGoogle ScholarPubMed
18.Reihner, E, Grunditz, R, Giesecke, K et al. Postoperative nausea and vomiting after breast surgery: efficacy of prophylactic ondansetron and droperidol in a randomized placebo-controlled study. Eur J Anaesthesiol 2000; 17: 197–203.CrossRefGoogle Scholar
19.Apfel, CC, Laara, E, Koivuranta, M et al. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology 1999; 91: 693–700.CrossRefGoogle Scholar
20.Tramer, MR. Clinical pharmacology : postoperative nausea and vomiting. Anaesthesist 2007; 56: 679–685.Google Scholar
21.Nakamura, E, Imasaki, H, Takeshige, T et al. Metabolic fate of ramosetron hydrochloride (2): absorption, distribution and excretion after oral administration of 14C-Ramosetron hydrochloride to rats. Drug Metab Pharmacokinet 1995; 10: 808–818 (in Japanese).CrossRefGoogle Scholar
22.Fu, Y, Yang, S, Jeong, SH et al. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst 2004; 21: 433–476.CrossRefGoogle ScholarPubMed
23.Tang, J, Wang, B, White, PF et al. The effect of timing of ondansetron administration on its efficacy, cost-effectiveness, and cost-benefit as a prophylactic antiemetic in the ambulatory setting. Anesth Analg 1998; 86: 274–282.CrossRefGoogle ScholarPubMed
24.Wang, JJ, Ho, ST, Tzeng, JI et al. The effect of timing of dexamethasone administration on its efficacy as a prophylactic antiemetic for postoperative nausea and vomiting. Anesth Analg 2000; 91: 136–139.CrossRefGoogle ScholarPubMed
25.Sun, R, Klein, KW, White, PF. The effect of timing of ondansetron administration in outpatients undergoing otolaryngologic surgery. Anesth Analg 1997; 84: 331–336.CrossRefGoogle ScholarPubMed
26.Fujii, Y, Saitoh, Y, Tanaka, H et al. Ramosetron for preventing postoperative nausea and vomiting in women undergoing gynecological surgery. Anesth Analg 2000; 90: 472–475.Google ScholarPubMed
27.Fujii, Y, Tanaka, H, Ito, M. Ramosetron compared with granisetron for the prevention of vomiting following strabismus surgery in children. Br J Ophthalmol 2001; 85: 670–672.CrossRefGoogle Scholar
28.Fujii, Y, Tanaka, H, Kawasaki, T. Benefits and risks of granisetron versus ramosetron for nausea and vomiting after breast surgery: a randomized, double-blinded, placebo-controlled trial. Am J Ther 2004; 11: 278–282.CrossRefGoogle Scholar
29.Fujii, Y, Uemura, A, Tanaka, H. Prophylaxis of nausea and vomiting after laparoscopic cholecystectomy with ramosetron: randomised controlled trial. Eur J Surg 2002; 168: 583–586.CrossRefGoogle Scholar
30.Tantipalakorn, C, Srisomboon, J, Thienthong, H et al. Comparison of oral versus intravenous ramosetron in prevention of acute cisplatin-induced emesis: a randomized controlled trial. J Med Assoc Thai 2004; 87: 119–125.Google ScholarPubMed
31.Kazemi-Kjellberg, F, Henzi, I, Tramer, MR. Treatment of established postoperative nausea and vomiting: a quantitative systematic review. BMC Anesthesiol 2001; 1: 2.CrossRefGoogle ScholarPubMed
32.Hirata, T, Funatsu, T, Keto, Y et al. Pharmacological profile of ramosetron, a novel therapeutic agent for IBS. Inflammopharmacology 2007; 15: 5–9.CrossRefGoogle ScholarPubMed
33.Hirata, T, Funatsu, T, Keto, Y et al. Inhibitory effects of ramosetron, a potent and selective 5-HT3-receptor antagonist, on conditioned fear stress-induced abnormal defecation and normal defecation in rats: comparative studies with antidiarrheal and spasmolytic agents. J Pharmacol Sci 2008; 106: 264–270.CrossRefGoogle ScholarPubMed
34.Bauer, KP, Dom, PM, Ramirez, AM et al. Preoperative intravenous midazolam: benefits beyond anxiolysis. J Clin Anesth 2004; 16: 177–183.CrossRefGoogle ScholarPubMed
35.Sanjay, OP, Tauro, DI. Midazolam: an effective antiemetic after cardiac surgery – a clinical trial. Anesth Analg 2004; 99: 339–343.CrossRefGoogle ScholarPubMed
36.Fujii, Y, Tanaka, H. Randomized, double-blind, placebo-controlled, dosed-finding study of the antiemetic effects and tolerability of ramosetron in adults undergoing middle ear surgery. Clin Ther 2003; 25: 3100–3108.CrossRefGoogle ScholarPubMed