A Comparative Study of Palonosetron with Ondansetron for Prophylaxis of Postoperative Nausea and Vomiting (PONV) Following Laparoscopic Gynaecological Surgeries.

Background: Incidence of postoperative nausea and vomiting (PONV) in susceptible patients can be unacceptably high (70-80% reported incidence). This study was designed to evaluate the effect of palonosetron and ondansetron in preventing PONV in high-risk patients undergoing gynaecological laparoscopic surgery.

Methodology: In this randomised, controlled, double-blind trial, nonsmoking females 18-70 years and weighing 40-90 kg, scheduled for elective laparoscopic gynaecological surgeries, were enrolled into the ondansetron (Group A, n=65) or palonosetron (Group B, n=65) group. Palonosetron (1 mcg/kg 4) or ondansetron (0.1 mg/kg 4) were administered just before induction. Postoperatively, incidence of nausea, vomiting, PONV (scored on a scale of 0-3), need for rescue antiemetic, complete response, patient satisfaction, and adverse effects were evaluated for up to 48 h following surgery.

Results: The overall PONV scores and postoperative nausea score during 0-2 h and 24-48 h were comparable, but PONV scores (P=0.023) and postoperative nausea scores (P=0.010) during 2-24 h were significantly lesser in Group B compared to Group A. There was no statistically significant difference in the postoperative vomiting score or retching during 0-48 h. The amount of first-line rescue antiemetic used during 2-24 h was significantly higher in Group A (56%) than in Group B (31%) (P=0.012; P<0.05). Complete response to the drug during 2-24 h was significantly higher (P=0.023) in Group B (63%) compared to Group A (40%), whereas response was comparable during 0-2 h and 24-48 h. Both groups had comparable incidences of adverse effects and patient satisfaction scores.

Conclusion: Palonosetron has superior antinausea effect, less need of rescue antiemetics, and lesser incidence of total PONV in comparison to ondansetron during 2-24 h and comparable effect to ondansetron during the 0-2 h and 24-48 h postoperative periods in high-risk patients undergoing gynaecological laparoscopic surgery.