Key result
Palonosetron reduces PONV by ~38% versus ondansetron in high-risk women undergoing gynecological surgery.
Why the study?
Postoperative nausea and vomiting incidence can reach 70-80% in susceptible patients, motivating evaluation of palonosetron versus ondansetron for prevention in high-risk patients undergoing gynecological laparoscopic surgery.
Does palonosetron reduce postoperative nausea and vomiting compared to ondansetron in non-smoking females undergoing elective laparoscopic gynecological surgeries?
RCT (n=130)
Double-blind
Simple randomization (chit-in-box system)
No
Does palonosetron reduce postoperative nausea and vomiting compared to ondansetron in non-smoking females undergoing elective laparoscopic gynecological surgeries?
Absolute Event Rate: 37% vs 60%
p-value: p=0.023
Palonosetron provides superior anti-nausea effects and reduces the need for rescue antiemetics compared to ondansetron during the 2-24 hour postoperative period in high-risk patients undergoing gynecological laparoscopic surgery.
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 gynecological laparoscopic surgery. Methodology In this randomized, controlled, double-blind trial, non-smoking females aged 18-70 years, weighing 40-90 kg, and posted for elective laparoscopic gynecological surgeries were enrolled into ondansetron (Group A, n = 65) and palonosetron (Group B, n = 65) groups. Palonosetron (1 mcg/kg IV) or ondansetron (0.1 mg/kg IV) were administered just before induction. Postoperatively, the 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 up to 48 h following surgery. Normally distributed continuous variables were compared using Student's t-test. In addition, the Chi-squared test or Fisher's exact test were used to compare nominal categorical data as deemed appropriate. P-value <0.05 was observed as statistically significant. Results The overall PONV scores and postoperative nausea scores during 0-2 and 24-48 hours were comparable, but PONV scores (p = 0.023) and postoperative nausea scores (p = 0.010) during 2-24 hours 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 hours. The amount of first-line rescue antiemetic used during 2-24 hours was significantly higher in Group A (56%) than in Group B (31%) (p = 0.012; p <0.05). A complete response to the drug during 2-24 hours was significantly higher (p = 0.023) in Group B (63%) compared to Group A (40%), whereas response was comparable during 0-2 and 24-48 hours. Both groups had a comparable incidence of adverse effects and patient satisfaction scores. Conclusion Palonosetron has a superior anti-nausea effect, less need for rescue antiemetics, and lesser incidence of total PONV compared to ondansetron during 2-24h and comparable effect to ondansetron during 0-2h and 24-48h postoperative period in high-risk patients undergoing gynecological laparoscopic surgery.
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Balyan et al. (2022) conducted an RCT in Postoperative nausea and vomiting (PONV) (n=130). Palonosetron vs. Ondansetron 0.1 mg/kg IV (maximum 8 mg) was evaluated on Incidence of overall PONV during 2-24 hours postoperatively (p=0.023). Palonosetron significantly reduced the incidence of postoperative nausea and vomiting compared to ondansetron during the 2-24 hour postoperative period (37% vs 60%, p=0.023) in high-risk women undergoing laparoscopic gynecological surgery.
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