Comparing combination antiemetics of ramosetron and dexamethasone to ondansetron and dexamethasone in middle ear surgery in high risk patients: a prospective, randomized double-blind clinical study

Abstract

Context: Combination antiemetics are recommended as prophylaxis for PONV in moderate to high risk patients. Commonly dexamethasone and 5 HT3 receptor antagonists are used as combination antiemetics. There is questionable benefit of adding dexamethasone to ramosetron for PONV prophylaxis. There are no studies comparing efficacy of combination of dexamethasone with single dose of ondansetron and ramosetron. Aims: To evaluate the efficacy of ramosetron and dexamethasone combination and compare it with ondansetron and dexamethasone in preventing PONV after middle ear surgery under general anaesthesia, in patients who are moderate to severe risk of PONV. Settings and Design: Peri-operative and up to 48 hours postoperative. Prospective, randomised, double blind study. Methods and Material: One hundred and forty four adult patients undergoing middle ear surgeries were allocated to receive either dexamethasone 8 mg and ondansetron 4 mg (n = 72) or dexamethasone 8mg and ramosetron 0.3 mg (n = 72). The incidence and severity of PONV, need of rescue antiemetics and the side effects of the antiemetics were noted for the first 48 h after surgery. Statistical analysis used: Chi-square test or Fisher’s exact test, independent sample t-test. Results: There was no significant difference in the incidence and severity of nausea between groups at 2, 2-12, 12-24 and 24-48 hour interval. The incidence of vomiting and use of rescue antiemetic was also not different between groups at all the time intervals. Percentage of patients with no PONV in 48 hours was 78% and 76% in dexamethasone ondansetron and dexamethasone ramosetron groups respectively. Conclusions: Combination of dexamethasone and ramosetron has equal efficacy as ondansetron with dexamethasone in reducing PONV after middle ear surgery. Key-words: Postoperative nausea and vomiting, Middle ear surgery, Ondansetron, Ramosetron, Dexamethasone. Key Message: Combination of dexamethasone and ramosetron has equal efficacy as