Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study

Abstract

BackgroundPostoperative nausea and vomiting (PONV) continues to be a major problem, because PONV is associated with delayed recovery and prolonged hospital stay. Although the PONV guidelines recommended the use of 5-hydroxy-tryptamine (5-HT3) receptor antagonists as the first-line prophylactic agents in patients categorized as high-risk, there are few studies comparing the efficacies of ondansetron, ramosetron, and palonosetron. The aim of present study was to compare the prophylactic antiemetic efficacies of three 5HT3 receptor antagonists in high-risk patients after laparoscopic surgery.MethodsIn this prospective, randomized, double-blinded trial, 109 female nonsmokers scheduled for elective laparoscopic surgery were randomized to receive intravenous 4 mg ondansetron (n = 35), 0.3 mg ramosetron (n = 38), or 75 µg palonosetron (n = 36) before anesthesia. Fentanyl-based intravenous patient-controlled analgesia was administered for 48 h after surgery. Primary antiemetic efficacy variables were the incidence and severity of nausea, the frequency of emetic episodes during the first 48 h after surgery, and the need to use a rescue antiemetic medication.ResultsThe overall incidence of nausea/retching/vomiting was lower in the palonosetron (22.2%/11.1%/5.6%) than in the ondansetron (77.1%/48.6%/28.6%) and ramosetron (60.5%/28.9%/18.4%) groups. The rescue antiemetic therapy was required less frequently in the palonosetron group than the other groups (P < 0.001). Kaplan-Meier analysis showed that the order of prophylactic efficacy in delaying the interval to use of a rescue emetic was palonosetron, ramosetron, and ondansetron.ConclusionsSingle-dose palonosetron is the prophylactic antiemetics of choice in high-risk patients undergoing laparoscopic surgery.

Refractory nausea and vomiting in the setting of well-controlled idiopathic intracranial hypertension

“…Palonosetron, a 5-HT3 antagonist with a half-life of 40 h and improved side-effect profile compared with others in its class, has been demonstrated to be superior to ondansetron, ramosetron and placebo for postoperative nausea prevention 2 3. Highlighting the complexity of treating refractory nausea, this case describes palonosetron being successfully used for nausea and vomiting, as well as class switching and switching therapy within classes.…”

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.…”

“…Reports of recent clinical studies 30,[39][40][41] showed that granisetron, ramosetron, and palonosetron had similar rates of associated adverse effects when used to prevent PONV, and in general, the incidence of common adverse events seemed to be similar among different 5-HT 3 RAs. With regard to serious adverse events, however, significant differences between palonosetron and ondansetron may exist.…”

“…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.…”