Efficacy of intravenous amisulpride and ondansetron in preventing post-operative nausea and vomiting in patients undergoing craniotomy for supratentorial tumour surgery: A randomised non-inferiority trial.

BACKGROUND AND AIMS: Patients undergoing neurosurgical procedures are at a high risk of post-operative nausea and vomiting (PONV). Amisulpride, a dopamine (D2, D3) receptor antagonist, has been recently approved for intravenous use in antiemesis and has demonstrated safety and efficacy in managing PONV in non-neurosurgical settings. We hypothesised that amisulpride would be non-inferior to ondansetron in preventing PONV.

METHODS

Adult patients scheduled for elective supratentorial craniotomy for tumour surgery under general anaesthesia were randomised to receive either intravenous amisulpride (5 mg) or intravenous ondansetron (4 mg) intra-operatively, administered 30 minutes before skin closure. Patients were then assessed for PONV in the post-operative intensive care unit. The primary objective was to evaluate the incidence of nausea and vomiting in the first 24 hours post-operatively. Secondary outcomes included nausea severity, the need for rescue antiemetic medications, and treatment-related adverse events. Incidence of PONV was compared using the Chi-square test. Secondary outcomes like severity of nausea, rescue medications, and adverse events were tested using Chi-square/Fisher's exact test. Non-inferiority of amisulpride to ondansetron was assessed using the pre-specified absolute non-inferiority margin of 20%.

RESULTS

A total of 100 patients were included in the final analysis. The incidence of nausea and vomiting was significantly lower in the amisulpride group (22% and 8%) compared to the ondansetron group (36% and 8%) (P = 0.032 and P = 0.045, respectively). Nausea severity was also significantly lower in the amisulpride group during the first four post-operative hours (P < 0.05). Additionally, patients receiving amisulpride required fewer rescue antiemetics. No treatment-related adverse events were observed in the amisulpride group.

CONCLUSION

A single intra-operative intravenous dose of amisulpride (5 mg) at the end of the surgery was found to be non-inferior to 4 mg intravenous ondansetron in reducing the incidence and severity of PONV in patients undergoing supratentorial craniotomy.