ABSTRACT
Background: Post-operative nausea and vomiting continues to be a common side effect of surgery and anaesthesia, affecting the economics of medical care, as well as the degree of patients’ satisfaction, comfort and quality of life.The objective of the present study were to compare the efficacy and safety of palonosetron versus placebo for prophylaxis of early onset (within 24 hours post-surgery) and late onset (24-72 hours post-surgery) post-operative nausea or vomiting in patients undergoing elective major surgery under general anaesthesia.Methods: A prospective, randomized, parallel group, two arm, double blind placebo controlled trial was conducted on n=100 indoor patients undergoing elective major surgeries were enrolled into the present study.Results: The patients showing complete response were 32 (64%) in palonosetron group and 19 (38%) in the placebo group (p<0.05) in the 0-24 hour time interval. The patients receiving palonosetron showed higher complete response rates in the 0-24 hour and 0-72 hour time intervals. 42 patients (84%) on palonosetron and 30 (60%) on placebo showed complete control of vomiting in 0-24 hour period. Adverse events related to the drug were reported in 5 patients (10%) in palonosetron group as compared to 3 patients (6%) in placebo group.Conclusions: A single prophylactic 0.075 mg IV dose of palonosetron effectively reduced the occurrence and severity of nausea and vomiting and delayed the time to emesis and treatment failure in the early as well as the overall postoperative period of 72 hours.