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.