Real-world Evaluation of Intravenous Amisulpride in Postoperative Nausea and Vomiting Prevention in India.

Background: The efficacy and safety of intravenous amisulpride in the prevention of postoperative nausea and vomiting (PONV) is established in adult surgical patients; however, evidence in the Indian population is lacking. The phase IV, multicenter, single-arm clinical trial evaluated the efficacy and safety of intravenous amisulpride in preventing PONV in Indian adults undergoing surgery. Materials and methods: Adult patients undergoing elective surgery during general anesthesia with ≥2 Apfel risk factors for PONV were enrolled at six centers in India. A single 5 mg IV dose of amisulpride was given at the induction of general anesthesia in adult elective surgery patients. The primary endpoint was the proportion of patients without an episode of emesis (vomiting or retching) or use of rescue medication in the first 24 hours after surgery. The secondary endpoints included evaluation of other predefined efficacy assessments and safety profile. Results: Out of 205 screened, a total of 200 patients were randomized and dosed with study medication. In the first 24 hours after surgery, 55.5% patients were free from any episode of emesis or use of rescue medication. No nausea episode was reported in 53% patients at 1 hour, 2 hours, 6 hours and 69.5% patients at 24 hours. Significant nausea (≥4 on verbal response scale) was observed in 40.5% patients at 1 and 2 hours, 37% patients at 6 hours, and 3% at 24 hours after surgery. The use of rescue medication for PONV was at 37.5% patients after 24 hours. Overall, the safety profile was benign with the majority of adverse events reported as mild in nature. Conclusion: Intravenous amisulpride is an effective and safe option for prevention of PONV in Indian patients undergoing elective surgery. How to cite this article: Shah HJ, Pariyani J, Shinde KV,