A Clinical Evaluation of Amisulpride in Prevention of Postoperative Nausea and Vomiting
Introduction
Postoperative nausea and vomiting (PONV) is a common complication affecting a significant proportion of surgical patients, with higher risk linked to Apfel factors. Despite prophylaxis using 5‑HT3 antagonists and dexamethasone, many patients still experience PONV, and existing rescue drugs are limited by modest efficacy and adverse effects. Amisulpride, a D2/D3 antagonist, has emerged as a promising alternative due to better safety and efficacy. Studies show improved outcomes over placebo, and it has been approved in the US (2020) and India (2023) for the prevention and treatment of PONV, with the condition of conducting phase IV clinical trials in Indian population.
Aim
To assess the efficacy and safety of intravenous amisulpride for prevention of PONV in patients undergoing elective surgery.
Method
Study Design
- Multicenter, single-arm, open-label clinical trial
Patient Profile
- Adults aged 18–75 undergoing elective laparoscopic gynecological or abdominal surgery under general inhalational anesthesia >1 hour, with ≥2 Apfel risk factors and ASA I–III,
Treatment Strategy
- Eligible patients received a single 5 mg intravenous (IV) dose of amisulpride infused slowly over 1-2 min at the time of induction of anesthesia
- Four study visits were conducted: screening (3 days prior to randomisation), baseline visit (day 1), end-of-study visit (day 2), safety follow-up visit (day 7)
- Within 24 hours post-surgery, nausea, vomiting (emesis), and rescue medication use were assessed
- Data were analysed using descriptive statistics
Endpoints
Primary Endpoints
- Proportion of patients without emesis or use of rescue therapy within 24 hours of surgery
Secondary Endpoints
- At 1, 2, 6 and 24 hours, proportion of patients with no nausea, significant nausea and episode of emesis
- Proportion of patients requiring rescue medication within 24 hours
Safety Endpoints
- Incidence of adverse events (AEs)
Results
- The study included analysis of 200 patients
- No episode of emesis and need for rescue therapy was reported by 55.5% within 24 hours of surgery
- Episode of emesis was reported by 44.5%
- Rescue therapy within 24 hours was required by 37.5%
- At 1, 2, 6 and 24 hours, no nausea episode was reported in 53%, 53%, 53% and 69.5% vs significant nausea was observed in 40.5%, 40.5%, 37% and 3% respectively
- The incidence of AEs was 32.5% of which majority were mild in nature
Conclusion
- An intravenous dose of amisulpride 5 mg was effective and safe in the prevention of postoperative nausea and vomiting in Indian patients undergoing elective surgery under general anesthesia.
Euroasian J Hepato-Gastroenterol. 2025;15(2):146-150. Doi: 10.5005/jp-journals-10018-1491.
