Key result
Palonosetron plus dexamethasone boosts complete PONV response to ~93% versus ondansetron alone.
Why the study?
Postoperative nausea and vomiting (PONV) is a common complication after surgery, and the comparative effectiveness of different antiemetic regimens in moderately high-risk patients was unclear.
Does palonosetron alone or in combination with dexamethasone reduce postoperative nausea and vomiting in adult female patients undergoing gynecological laparoscopic procedures compared to ondansetron?
RCT (n=160)
Double-blind
Computer-generated random number chart
No
Does palonosetron alone or in combination with dexamethasone reduce postoperative nausea and vomiting in adult female patients undergoing gynecological laparoscopic procedures compared to ondansetron?
Absolute Event Rate: 92.5% vs 57.5%
p-value: p=0.012
A combination of palonosetron and dexamethasone is more effective than ondansetron or palonosetron alone for preventing postoperative nausea and vomiting in moderately high-risk patients undergoing laparoscopic procedures.
Supports palonosetron-dexamethasone over ondansetron for PONV prevention in gynecologic laparoscopy; extends RCT evidence for combination regimens in high-risk procedures.
Background : Postoperative nausea and vomiting (PONV) is one of the common complications after surgery. This randomized double-blind study was planned to compare the effectiveness of different antiemetic regimens for PONV prophylaxis in moderately high-risk patients. Methods : One hundred and sixty adult ASA grade I-II female patients undergoing day care gynecological laparoscopic procedures were randomly allocated into four groups. Group 1 patients (Control group) received 4 mg ondansetron, group 2 (P75 group) patients received 0.075 mg palonosetron, group 3 (P150 group) patients received 0.150 mg palonosetron, and group 4 (PD group) patients received 0.075 mg palonosetron and 8 mg dexamethasone after induction of anesthesia. Anesthesia was induced with propofol and fentanyl, and maintained with N2O-isoflurane in oxygen. The number of complete responders, frequency of nausea and vomiting episodes and the requirement of rescue antiemetic during 0-6 h, 6-24 h and 24-72 h after surgery were recorded. Results : Patients receiving dexamethasone and palonosetron combination had significantly less vomiting (p = 0.03) and required less rescue antiemetic as compared to Control group (p = 0.014). The incidence of nausea was low in all palonosetron groups as compared to the ondansetron group. The complete response rate was significantly high in the PD group as compared to other groups (p = 0.012). There was no significant difference in nausea and vomiting in patients receiving palonosetron 0.075 mg or 0.15 mg. Conclusions : We conclude that a dexamethasone-palonosetron combination is more effective than ondansetron and palonosetron alone for the prevention of PONV, while palonosetron 0.150 mg has no significant benefit over 0.075 mg for PONV prophylaxis in moderately high-risk patients.
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Bharti et al. (2020) conducted an RCT in Postoperative nausea and vomiting (PONV) (n=160). Palonosetron and dexamethasone vs. 4 mg ondansetron was evaluated on Complete response rate (no emesis and no rescue antiemetic) during 0-72 hours (p=0.012). A combination of palonosetron and dexamethasone significantly increased the complete response rate for PONV prophylaxis to 92.5% compared to 57.5% with ondansetron alone in patients undergoing gynecological laparoscopy.
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