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

Background: Postoperative 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.

Methods: In 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.

Results: The 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.

Conclusions: Single-dose palonosetron is the prophylactic antiemetics of choice in high-risk patients undergoing laparoscopic surgery.

Keywords: Ondansetron; Palonosetron; Postoperative nausea and vomiting; Prophylaxis; Ramosetron.

Fig. 1

Kaplan-Meier analysis of the intervals before administering the first dose of rescue antiemetic in the palonosetron, ondansetron, and ramosetron groups. Significant differences were observed between the palonosetron and ondansetron (P < 0.001), palonosetron and ramosetron (P < 0.001), and ondansetron and ramosetron (P = 0.042) groups.

Fig. 2

(A) Postoperative pain scores (VAS) at 1 h, 6 h, 24 h, and 48 h after surgery in the palonosetron, ondansetron, and ramosetron groups. Data are shown as box plots with ranges (whiskers), interquartile ranges (boxes), medians (solid lines), and means (bold lines). There was no difference in VAS pain score among the groups during the study period. (B) Total amounts of fentanyl administered via intravenous patient-controlled analgesia (IV-PCA) in the 3 groups during 48 h after surgery. Data are shown as mean with SD.