Amisulpride for Postoperative Nausea and Vomiting

Overseen By David B Auyong, Medical Doctor

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Benaroya Research Institute

Must not be taking: Droperidol

Disqualifiers: Pregnancy, Congenital QTc, Parkinson's, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using droperidol.

What data supports the effectiveness of the drug amisulpride for postoperative nausea and vomiting?

Research shows that intravenous amisulpride is effective in preventing and treating postoperative nausea and vomiting (PONV) in adults, even when other anti-nausea drugs have failed. It has been tested in multiple studies and found to be safe and well-tolerated, making it a useful option for managing PONV. ^{1 2 3 4 5}

Is intravenous amisulpride safe for humans?

Intravenous amisulpride, used to prevent and treat postoperative nausea and vomiting, has a safety profile similar to a placebo, with no significant safety concerns identified in trials. It has a long history of safe use in oral form as an antipsychotic, and in clinical trials, it was generally well tolerated with fewer side effects compared to some other antipsychotics. ^{1 2 4 6 7}

How is the drug amisulpride different from other treatments for postoperative nausea and vomiting?

Amisulpride is unique because it is a selective dopamine receptor antagonist given as a single intravenous infusion, making it effective for both preventing and treating postoperative nausea and vomiting, especially in patients who have not responded to other antiemetics. Unlike common treatments like 5HT3 antagonists, amisulpride can be used as a rescue option when other medications fail. ^{1 2 3 4 7}

Research Team

Justin S Liberman, Medical Doctor

Principal Investigator

Virginia Mason Medical Center

Eligibility Criteria

Adults aged 18-65 scheduled for bariatric surgery (like gastric bypass or sleeve gastrectomy) can join this study. They should be in good enough health for surgery (ASA class I-III) and plan to stay in the hospital at least a day after.

Inclusion Criteria

I have had or am planning to have weight loss surgery.

I am between 18 and 65 years old, scheduled for weight loss surgery, and will stay in the hospital for at least a day.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous dose of Amisulpride or placebo at the induction of anesthesia

1 day

1 visit (in-person)

Post-Anesthesia Care Unit (PACU)

Participants who initially received placebo may receive Amisulpride or placebo as first line treatment for PONV

60-120 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the treatment for up to 24 hours following surgery

24 hours

Treatment Details

Interventions

• Amisulpride

Trial Overview The trial is testing Amisulpride, given through an IV, against a placebo to see if it can prevent or treat nausea and vomiting after weight-loss surgery. Participants will randomly receive either the drug or placebo.

Participant Groups

Group I: Group Placebo Barhemsys Experimental Treatment 1 Intervention

Of patients who are members of Group Placebo they will be able to receive Barhemsys in the Post Anesthesia Care Unit if they experience nausea or emesis

Group II: Group Barhemsys Experimental Treatment 1 Intervention

Interventional arm receiving Barhemsys during surgery

Group III: Group Placebo Placebo Group 1 Intervention

Placebo arm receiving Placebo during surgery

Group IV: Group Placebo Placebo Placebo Group 1 Intervention

Of patients who are members of Group Placebo they will be able to receive Placebo in the Post Anesthesia Care Unit if they experience nausea or emesis

Amisulpride is already approved in European Union, United States for the following indications:

Approved in European Union as Solian for:

• Schizophrenia
• Acute psychotic episodes
• Depression

Approved in United States as Barhemsys for:

• Prevention and treatment of postoperative nausea and vomiting in adults

Who Is Running the Clinical Trial?

Benaroya Research Institute

Lead Sponsor

Trials

50

Recruited

12,300+

Virginia Mason Hospital/Medical Center

Collaborator

Trials

23

Recruited

8,500+

Findings from Research

Intravenous amisulpride has been approved as an effective antiemetic for preventing and treating postoperative nausea and vomiting (PONV), addressing a significant issue in surgical recovery for patients.

The review highlights that amisulpride, with a history of safe use as an oral antipsychotic, can serve as a valuable addition to PONV management, especially for patients who do not respond to standard prophylactic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting. Fox, G., Kranke, P.[2022]

In a study involving 560 surgical patients experiencing postoperative nausea and vomiting (PONV), intravenous amisulpride at doses of 5 and 10 mg significantly improved the complete response rate compared to placebo, with 31.4% of patients in both amisulpride groups achieving no vomiting and not requiring rescue medication.

Amisulpride was found to be safe, with an adverse event profile similar to that of placebo, indicating it can be an effective treatment option for established PONV in patients who did not receive prior prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Candiotti, KA., Kranke, P., Bergese, SD., et al.[2023]

Amisulpride significantly improves the prevention and treatment of postoperative nausea and vomiting (PONV) compared to placebo, with a relative risk of complete response at 1.30 based on a systematic review of five studies involving 3243 patients.

The safety profile of amisulpride is comparable to that of placebo, indicating that low-dose intravenous amisulpride is a safe option for managing PONV, although further research is needed to determine the best dosing and timing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of amisulpride on postoperative nausea and vomiting: a systematic review and meta-analysis. Zhang, LF., Zhang, CF., Tang, WX., et al.[2021]

IV amisulpride is an effective treatment for preventing and treating post-operative nausea and vomiting (PONV) in adults, based on results from phase III trials that showed its efficacy both alone and in combination with other antiemetics.

The safety profile of IV amisulpride is comparable to that of a placebo, indicating it is well-tolerated with no significant safety concerns, making it a valuable option for patients who have not responded to other antiemetic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amisulpride: A Review in Post-Operative Nausea and Vomiting. Kang, C., Shirley, M.[2021]

In a study involving 689 surgical patients, intravenous amisulpride significantly reduced the incidence of postoperative nausea and vomiting compared to placebo, with a complete response rate of 46.9% in the U.S. trial and 57.4% in the European trial.

Amisulpride was found to have a similar safety profile to placebo, with no significant differences in side effects such as QT prolongation or sedation, indicating it is a safe option for preventing postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled Trials. Gan, TJ., Kranke, P., Minkowitz, HS., et al.[2018]

Amisulpride is an effective treatment for schizophrenia, showing comparable efficacy to haloperidol, risperidone, and olanzapine for patients with predominantly positive symptoms, and significantly better results than placebo for those with predominantly negative symptoms at lower doses (50-300 mg/day).

Amisulpride is generally well tolerated, with a lower incidence of extrapyramidal side effects compared to haloperidol, and it causes less weight gain than risperidone or olanzapine, making it a favorable option for both acute and long-term treatment of schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amisulpride: a review of its use in the management of schizophrenia. McKeage, K., Plosker, GL.[2022]

In a study of 215 adult surgical patients at risk for postoperative nausea and vomiting (PONV), the D2/D3-antagonist APD421 (amisulpride) significantly reduced the incidence of PONV, particularly at a dose of 5 mg, compared to placebo.

APD421 demonstrated a safety profile similar to placebo, with no significant central nervous system or cardiac side effects, making it a promising option for PONV prophylaxis in moderate to high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Kranke, P., Eberhart, L., Motsch, J., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of amisulpride on postoperative nausea and vomiting: a systematic review and meta-analysis. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Amisulpride: A Review in Post-Operative Nausea and Vomiting. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled Trials. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Amisulpride: a review of its use in the management of schizophrenia. [2022]

7. England pubmed.ncbi.nlm.nih.gov

I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. [2018]