Efficacy and Safety of Intravenous Palonosetron against Ondansetron in Preventing Postoperative Nausea Vomiting in Patients Undergoing General Anaesthesia: Double blind Randomized Control Study in Tertiary Care Hospital, Tamil Nadu, India

Abstract

Background Post operative nausea vomiting (PONV) is distressing for patient as well as clinician as it affects post-operative care and recovery substantially. Causes of PONV are multi factorial which are primarily categorized into patient related factors, pre- surgical factors and post-surgical factors. There are several classes of drugs that constitute basic of anti-emetic therapy. Primary objective of the study is to assess the efficacy and safety of intravenous (IV) Palonosetron in preventing post operative nausea vomiting (PONV) in comparison with IV ondansetron. Methodology This is a double blinded randomized controlled study conducted during the period of January 2015 to February 2016 in patients with ASA (American Society of Anesthesiologist) grade I category who underwent surgical intervention under general anaesthesia. Both male and female patients in the age range of 15-60 years with ASA grade I status and willing to give written informed consent were recruited for the study. 116 out of 129 patients were recruited for the study based upon inclusion and exclusion criteria. The patients were randomly assigned to two equal groups, Group A, who received palonosetron 0.075 mg intravenously and Group B, who received ondansetron 8 mg intravenously. The efficacy and safety of palonosetron was tested on the use of ondansetron. Statistical analysis was done by Chi-square test and Student t-test. P value less than 0.05 was considered statistically significant. Results Efficacy of palonosetron was assessed by complete response (CR), use of rescue medication, gratification score and severity of nausea. The P value of all efficacy parameters was <0.05 which was statistically significant. Safety parameters include adverse reactions related to palonosetron or other adverse drug events. Adverse drug reactions were less in group A compared to Group B. Conclusion Palonosetron was more efficacious than ondansetron in controlling PONV in a post-surgical patient undergoing general anaesthesia. Palonosetron was found equally safe as ondansetron.