Comparison of ramosetron, dexamethasone, and a combination of ramosetron and dexamethasone for the prevention of postoperative nausea and vomiting in Korean women undergoing thyroidectomy: A double-blind, randomized, controlled study.

BACKGROUND: Thyroidectomy is associated with a relatively high incidence of postoperative nausea and vomiting (PONV), ranging from 51% to 76%. Because these symptoms are distressing for patients, prophylactic medication to avoid or reduce PONV is recommended.
OBJECTIVE: The aim of the present study was to compare the efficacy of ramosetron, dexamethasone, and a combination of ramosetron and dexamethasone in preventing PONV in Korean women undergoing thyroidectomy.
METHODS: In this double-blind, randomized, controlled trial, consecutive adult female patients who were scheduled to undergo thyroidectomy under general anesthesia at the Kyungpook National University Hospital (Daegu, Korea) were randomly assigned to receive ramosetron 0.3 mg alone, dexamethasone 8 mg alone, or a combination of ramosetron 0.3 mg and dexamethasone 8 mg administered intravenously as a single dose immediately after induction of anesthesia. The primary end point of this study was the total PONV rate up to 24 hours postanesthesia. The secondary end points were the incidence of nausea, incidence of vomiting, severity of nausea (0 = no nausea to 10 = nausea as bad as it could be), use of rescue antiemetic drugs, and the occurrence of adverse events (AEs) determined through interview or spontaneous patient report for 24 hours postanesthesia.
RESULTS: A total of 198 female patients were approached for study inclusion, 18 of whom were excluded. Therefore, 180 Korean women (mean [SD] age, 46.5 [12.6] years; height, 159.8 [2.7] cm; weight, 53.2 [3.6] kg) were enrolled and completed the study. The total PONV rates up to 24 hours postanesthesia were 35%, 13%, and 10% in the dexamethasone, ramosetron, and combination groups, respectively. The PONV rate was significantly lower in the combination group than in the dexamethasone alone group (P = 0.006). The PONV rate was not significantly different in the combination group compared with the ramosetron alone group. The PONV rate in the dexamethasone alone group was significantly higher than that in the ramosetron alone group (P = 0.03). The severity of nausea (median [25th-75th percentiles], 0 [0-0] vs 0 [0-4]; P = 0.009) and rate of use of rescue antiemetic drugs (5% vs 27%; P = 0.006) were significantly lower in the combination group than in the dexamethasone alone group, whereas the severity of nausea (median [25th-75th percentiles], 0 [0-0] vs 0 [0-0]) and rate of use of rescue antiemetic drugs (5% vs 7%) were not significantly different between the combination and ramosetron alone groups. The severity of nausea (median [25th-75th percentiles], 0 [0-4] vs 0 [0-0]; P = 0.033) and the rate of use of rescue antiemetic drugs (27% vs 7%; P = 0.018) were significantly higher in the dexamethasone alone group than in the ramosetron alone group. The rates of AEs (headache: 15%, 20%, and 18%; dizziness: 18%, 22%, and 15%) were not significantly different in the dexamethasone alone, ramosetron alone, or combination groups, respectively.
CONCLUSIONS: The combination of ramosetron and dexamethasone was more effective in reducing PONV than was dexamethasone monotherapy. However, the combination did not show additional benefits compared with ramosetron alone in preventing PONV after thyroidectomy in these Korean women.

RCT Entities:   Population Interventions Outcomes