Intravenous amisulpride as rescue treatment of postoperative nausea and vomiting in patients undergoing oncologic surgical procedures.

12111 Background: Nausea and vomiting or retching after surgery can have significant adverse impacts, including increased length of stay, worse outcomes and patient dissatisfaction. Therefore, effective management remains a high priority. While more aggressive, multimodal prophylaxis has helped, options for treating those patients who fail are limited. Intravenous (IV) amisulpride has been shown to be safe and effective for the rescue treatment of Post-Operative Nausea and Vomiting (PONV) in a large, randomized, double-blind, placebo-controlled trial in a broad surgical population (Habib AS, Kranke P, Bergese SD, Chung F, et al. Anesthesiology 2019;130:203-212). We conducted a post-hoc analysis to investigate the safety and efficacy of amisulpride specifically in those patients undergoing oncologic surgery, predominantly excision of breast, gastrointestinal, or genitourinary malignancies. Methods: This subset analysis includes data from a randomized, double-blind, placebo-controlled, multicenter phase III trial of a single 10 mg dose of IV amisulpride as rescue treatment of PONV occurring in patients failing pre/peri-operative prophylaxis, generally with ondansetron and/or dexamethasone (Habib AS, Kranke P, Bergese SD, Chung F, et al. Anesthesiology 2019;130:203-212). The subset includes only those patients identified as undergoing surgery related to a specified malignancy or a mass considered likely to be malignant. The primary efficacy outcome was complete response (CR), defined as no emetic episodes (vomiting or retching) or administration of antiemetic rescue medication in the 24 hours after dosing. Results: In total, 465 patients were treated with either 10 mg amisulpride or placebo and 112 (56 in each group) underwent oncologic surgery. Of these, 43 (38%) underwent surgery for a pelvic tumor, 37 (33%) had breast or axillary surgery, 13 (12%) had colorectal, hepatic or pancreatic surgery and 19 (17%) underwent procedures for other malignancies, such as nephrectomy or thyroidectomy. The CR rate at 24 hours in the amisulpride group was 38%, compared to 23% with placebo. This was comparable with the success rates for the whole study population (42% vs 29%). The CR rate after 2 hours was 66% in the amisulpride group and 39% in the placebo group, also in line with the overall study results (70% vs 49%). Among those patients whose PONV occurred in the post-anesthesia care unit (PACU), the mean length of PACU stay from treatment to PACU discharge was 156 minutes in the amisulpride group and 230 minutes in the placebo group. Treatment-emergent adverse effects (TEAE) were comparable in nature and incidence between amisulpride and placebo. Conclusions: Amisulpride at 10 mg IV is safe and effective as rescue treatment for PONV in cancer patients undergoing surgery and is associated with a marked reduction in PACU length of stay.