Comparison Of Palonosetron With Placebo For Prevention Of Postoperative Nausea And Vomiting In Female Patients Undergoing Gynaecological Surgery Under Spinal Anaesthesia.

Abstract

Background: Postoperative Nausea and Vomiting (PONV) can be a distressing problem in patients undergoing regional anaesthesia also, as patient and surgical risk factors for PONV continue to exist. In this randomized, double blind, prospective clinical study, we investigated and compared the efficacy of newer 5HT3 antagonist Palonosetron, compared to placebo, in preventing Postoperative Nausea and Vomiting in patients undergoing gynaecological surgeries under spinal anaesthesia.Material and Methods: 70 women, ASA 1 and 2, undergoing gynaecological surgeries, with risk for PONV (>/= 2 risk score) were randomly allocated to two groups containing 35 patients each. One group received 0.075mg of Palonosetron intravenously and other group received saline intravenously as placebo after administration of spinal anaesthesia. Peri-operative anesthetic care was standardized in all patients. The efficacy of study medication was assessed in terms of Complete Response (No emesis and no rescue antiemetic), incidence of emetic episodes, the incidence and severity of nausea in the postoperative study periods 0-6 hours, 6-24 hours and 24-72 hours. Results: The incidence of a Complete Response (no emesis, no rescue antiemetic) in 0-6 hour study period was 82.9% with palonosetron group and 45.7%with placebo group (P value-0.001 strongly significant).The corresponding incidence in 6-24 hour was 74.3% with palonosetron and 37.1% with placebo group (P value 0.002 strongly significant).During 24-72 hour, the incidence was 97.1% in palonosetron and 94.3% in the placebo group (P value not significant).Conclusion: A single intravenous dose of 0.075mg of Palonosetron significantly reduced emesis, nausea and use of rescue anti-emetics in female patients undergoing gynaecological surgeries under spinal anaesthesia compared to placebo.