Palonosetron: A novel approach to control postoperative nausea and vomiting in day care surgery

Abstract

Background:Postoperative nausea and vomiting (PONV) is one of the complications which hamper the successful implementation of day care surgical procedure in spite of the availability of so many antiemetic drugs and regimens for its prevention. The aim was to compare the prophylactic effects of intravenously (IV) administered ondansetron and palonosetron on PONV prevention in patients undergoing laparoscopic gynecological surgery under general anesthesia.Methods:A prospective double-blind study comprised of 60 ASAI/II female patients between the age group of 25 and 40 years was carried out in the Departments of Anesthesiology and Obstetrics and Gynecology of our institute. Patients were randomly divided into two groups of 30 patients each in a double-blind manner. Group I received 8 mg of inj. ondansetron IV while group II received inj. palonosetron 0.075 mg IV 5 minutes before the induction of anesthesia. The need for rescue antiemetics, episodes of PONV and other side effects were observed for 6 hours in the postanesthesia care unit and thereafter complaints were received on phone after the discharge. At the end of study, results were compiled and statistical data was subjected to statistical analysis using Student two-tailed ‘t’ and χ2 test and value of P<0.05 was considered significant.Results:The demographical profile of the patients was comparable. Twenty and 13.33% of the patients in group I had nausea and vomiting episodes postoperatively as compared to 6.67% and 3.33%, respectively, in group II which was statistically significant (P<0.05). Twenty percent of the patients in group I experienced significant post-op headache as compared to 6.67% in group II. The mean rescue dose of antiemetic was significantly higher (10.6 mg) in the group I as compared to group II (6.4 mg) (P=0.036). The rest of parameters were comparable and statistically nonsignificant.Conclusions:Palonosetron is a comparatively better drug to prevent the PONV in patients undergoing day care surgical procedures as compared to ondansetron as it has got a prolonged duration of action and favorable side-effects profile.

A Comparative Study of Ondansetron and Palonosetron as Antiemetics for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgeries

“…In our study, incidence of headache was 9.7% in Ondansetron group and 2.4% in Palonosetron group which was found to be statistically significant (p=0.0331) as shown in Table B6 and comparable to study conducted by Bazwa SS et al (2011). 11 , in which 20% of the patients in Ondansetron group experienced significant post-op headache as compared to 6.67% in Palonosetron group. Unlikely, there was no significant difference in side effects observed in Park SK, Cho EJ (2011).…”

“…Overall incidence of vomiting in our study was 21.8% in Group O and 4% in Group P with p value of 0.0001 as shown in Table B5, Figure B5 which was statistically significant and comparable to results concluded by Bajwa SS (2011). 11 Park SK, Cho EJ (2011). 9 and Moon YE, Joo J, Kim JE, Lee Y (2012).…”

Efficacy of palonosetron for preventing postoperative nausea and vomiting: a systematic review and meta-analysis

“…We then retrieved the full texts of the remaining 16 citations and excluded seven of these citations because five among them had no intended interventions and two had no outcomes of interest. Altogether, nine studies [25][26][27][28][29][30][31][32][33] fulfilled the criteria for systematic review and meta-analysis. The study selection processes are shown in Fig.…”

“…In 2008, the FDA approved a single intravenous dose of palonosetron for PONV prophylaxis for up to 24 hours based on the results of two earlier dose-ranging studies. 48,49 Subsequently, most studies [25][26][27][28][29][30][31][32][33] chose palonosetron 0.075 mg as the dose to administer in their trials, which makes it difficult to re-evaluate the optimal dose of palonosetron.…”

“…Compared with ondansetron, the combined results of four studies indicated that palonosetron can significantly reduce the incidence of PON (RR, 0.53; 95% CI, 0.33 to 0.86) but not POV within 24 to 48 or 72 hr after surgery. 25,28,30,31 Given that the overall rate of POV (0-10%) is low at the 24-48 hr or 24-72 hr, these studies comparing palonosetron with placebo or ondansetron suffered from small sample sizes, and it was difficult to show a statistically significant difference. Thus, it is inappropriate to make conclusions regarding palonosetron's efficacy during the postoperative 24-72 hr; it calls for more RCTs to address this question.…”