Dual-Dose Aprepitant to Prevent Postoperative Nausea and Vomiting After Laparoscopic Bariatric Surgery: Pilot Data from a Prematurely Terminated, Randomised, Controlled Trial

Background & Objectives: Postoperative nausea and vomiting (PONV) is unpleasant and increases length of hospital stay, complications and costs. Despite prophylaxis, PONV rates remain high in patients at risk and continue to rise 24 to 48 h postoperatively. We hypothesise that adding two scheduled doses of aprepitant 80 mg to dexamethasone 8 mg and ondansetron 4 mg will reduce cumulative PONV in the first 48 h in patients with moderate to high risk for PONV undergoing laparoscopic bariatric surgery. Methods: In this prospective, randomised, placebo-controlled, triple-blind, single-centre, two-arm parallel-groups superiority trial, patients scheduled for elective laparoscopic bariatric surgery with an APFEL score ≥2 were randomised to placebo or aprepitant on the day of surgery and first postoperative day. The primary outcome was cumulative PONV (severe nausea, emesis or use of rescue medication) within 48 h after surgery. Secondary outcomes were use of opioids, non-opioid analgesics and co-analgesics, delayed PACU discharge, length of PACU and hospital stay and surgical complications (Clavien–Dindo) at 30 days. Results: After inclusion of 70 of 224 patients scheduled (31%) within 33 months (2022–2025), the trial was aborted due to a low recruiting rate. We included 65 patients in the analysis (modified intention-to-treat; verum = 33, placebo = 32). Cumulative PONV was 59.4% in the placebo versus 54.5% in the verum group (risk difference −4.8% [−27.2–18.3%], p = 0.887). There were fewer episodes of vomiting or retching in the aprepitant group from PACU discharge until first visit (p adj. = 0.048). There were no differences in other secondary outcomes and no adverse events related to the study medication. Conclusions: Superiority of dual-dose aprepitant in prevention of PONV after bariatric laparoscopic surgery in patients at risk has not been reached. The PONV rate did rise after discharge from the post-anaesthetic care unit until 48 h after surgery. Efficacy of repeated doses of aprepitant still needs to be confirmed.