A RANDOMIZED, DOUBLE-BLIND STUDY OF PALONOSETRON COMPARED WITH ONDANSETRON IN PREVENTING POSTOPERATIVE NAUSEA AND VOMITING AFTER MODIFIED RADICAL MASTECTOMY SURGERY.

Abstract

BACKGROUND : Palonosetron is a new potent 5-hydroxytryptamine 3 antagonist. Although used for chemo induced emesis, data is lacking for PONV. The high incidence of nausea and vomiting after breast surgery is well documented. This study compared the effects of i.v.ondansetron and palonosetron administered at the time of induction for preventing postoperative nausea and vomiting (PONV) in these high-risk patients . The aim was to compare Onda METHODS : nsetron 8 mg and Palonosetron 0.075mg administered intravenously for prevention of post operative nausea and vomiting in patients undergoing modied radical mastectomy 24 hours postoperatively, by a randomised , controlled, double blind study. 70 female non smoking patients scheduled for elective modied radical mastectomy were, allocated randomly into 2 groups . Patients received either Palonosetron 0.075mg (GROUP P ) or ondansetron 8mg ( GROUP O ) intravenously, immediately before induction of general anaesthesia. The occurence of nausea, vomiting, retching, need for rescue antiemetics and side effects were monitored for a period of 24 hours after surgery. The compete response rate and overall PONV for 0 - 24 hours were calculated. The demographic prole of the patients were comparable. The RESULTS : incidence of a complete response (no PONV, no rescue antiemetics ) during 0 - 24 hours in post operative period was signicantly high in GROUP P ( 85.7% vs 62.9%, p=0.02) than GROUP O. The incidence of nausea was signicantly low in GROUP P ( 14.3% vs 37.1%). There was no statistically signicant difference between the 2 groups in vomiting, retching, side effects and need for rescue antiemetics. Thus overall PONV was low in GROUP P (14.3% vs 37.1% p = 0.02 statistically signicant.) We conclude that Palonosetron 0.075mg was more effective for preventing PONV in patients undergoing modied radical mastectomy surgery