Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment

NCT04954365 | Withdrawn

• 1 other identifier: PROMPT
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

PROMPT (PONV Rescue Outcomes after AMisulPride Treatment) is an observational Phase IV study designed to evaluate real-world evidence in relation to the care continuum of Post Operative Nausea and Vomiting (PONV), as well as the effectiveness and safety of common pharmacologic rescue treatment regimens compared to IV amisulpride. There will be no predefined hypothesis regarding the magnitude of efficacy or safety of various treatment regimens from the cohorts observed. We are not proposing to directly recruit patients into this study.

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

• Time to PACU Discharge

  Time in mins from administration of first PONV rescue medication to discharge from post-anaesthesia care unit

  24 hours

Study Arms (2)

Cohort 1

Patients that received rescue treatment according to the standard of care (SOC).

Drug: Rescue Post-Operative Nausea and Vomiting (PONV) treatment according to the standard of care (SOC)

Cohort 2

Patients that received rescue treatment with IV amisulpride.

Drug: Amisulpride

Interventions

Rescue Post-Operative Nausea and Vomiting (PONV) treatment according to the standard of care (SOC) DRUG

Rescue Post-Operative Nausea and Vomiting (PONV) treatment

Cohort 1

Amisulpride DRUG

Rescue Post-Operative Nausea and Vomiting (PONV) treatment with Amisulpride

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients (age ≥ 18 years) having Post-Operative Nausea and Vomiting (PONV) during their Post-Anesthesia Care Unit (PACU) stay, regardless of type of surgery, anesthesia, pre-medication, comorbidities, etc.

You may qualify if:

• All adult patients (age ≥ 18 years)
• Patients having Post-Operative Nausea and Vomiting (PONV) during their Post-Anesthesia Care Unit (PACU) stay, regardless of type of surgery, anesthesia, pre-medication, comorbidities, etc.

Sponsors & Collaborators

• Acacia Pharma Ltd: lead
• ArborMetrix: collaborator

Related Publications (2)

• Candiotti KA, Kranke P, Bergese SD, Melson TI, Motsch J, Siddiqui N, Chung F, Rodriguez Y, Minkowitz HS, Ayad SS, Diemunsch P, Fox G. 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. Anesth Analg. 2019 Jun;128(6):1098-1105. doi: 10.1213/ANE.0000000000003733.

  PMID: 31094774 BACKGROUND

• Habib AS, Kranke P, Bergese SD, Chung F, Ayad S, Siddiqui N, Motsch J, Leiman DG, Melson TI, Diemunsch P, Fox GM, Candiotti KA. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial. Anesthesiology. 2019 Feb;130(2):203-212. doi: 10.1097/ALN.0000000000002509.

  PMID: 30475232 BACKGROUND

Related Links

• BARHEMSYS Prescribing Information

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Lynn Bichajian, MD

  Acacia Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 8, 2021
• Study Start: November 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04