Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery

NCT06887621 | Recruiting Phase 2 DMC

• 1 other identifier: 83804424.3.0000.0083
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

Amisulpride is a potent antagonist of dopamine D2 and D3 receptors, both implicated in the emetic response when activated. It is currently used intravenously for the prevention of chemotherapy-induced and postoperative nausea and vomiting (PONV), but this route has a short half-life time of 4 to 5 hours, could be expensive, causes infusion-related pain, and is not available in Brazil. Some of these limitations could be overcome by the preemptive use of an oral formulation. At present, there are no data regarding the use of oral amisulpride for PONV, which is an affordable and painless option with half-life time of 12 hours. We propose a quadruple-blind clinical trial involving patients undergoing gynecological surgery aged 18 years and older, and assessed as being at high risk for PONV according to the Apfel Score (score 3 or 4). The primary outcome of this study is to evaluate complete response to PONV up to 24h, comparing the efficacy of adding 50 mg oral amisulpride as a third antiemetic agent to the standard institutional protocol at the Hospital da Mulher of São Paulo (IV dexamethasone 10 mg + IV ondansetron 4 mg) for laparoscopic surgeries. Secondary outcomes will evaluate (1) nausea, (2) vomiting, (3) nausea and vomiting, (4) use of rescue treatment, (5) overall adverse events, and (6) adverse events.

Conditions

Post Operative Nausea and Vomiting (PONV)

Keywords

Amisulpride; Postoperative Nausea and Vomiting; Laparoscopy; Gynecologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Number of participants with complete response

  Complete response defined as the absence of emetic episodes (nausea, vomiting or retching) and no use of antiemetic medications.

  24 hours after the end of anesthesia

Secondary Outcomes (8)

• Time to first violation of the criteria for complete response

  24 hours after the end of anesthesia

• Number of participants with any nausea

  24 hours after the end of anesthesia

• Number of participants with vomiting

  24 hours after the end of anesthesia

• Number of participants with nausea and vomiting

  24 hours after the end of anesthesia

• PONV Intensity

  24 hours after the end of anesthesia

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo ● Dexamethasone 10 mg IV immediately after anesthesia induction ● Ondansetron 4 mg IV at the end of the surgical procedure.

Drug: Encapsulated placebo (matched for color, weight, smell and size)

Oral Amisulpride

EXPERIMENTAL

Amisulpride 50 mg ● Dexamethasone 10 mg IV immediately after anesthesia induction ● Ondansetron 4 mg IV at the end of the surgical procedure.

Drug: Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)

Interventions

Encapsulated amisulpride 50 mg (matched for color, weight, smell and size) DRUG

Amisulpride will be delivered orally 1 hour before anesthesia induction.

Oral Amisulpride

Encapsulated placebo (matched for color, weight, smell and size) DRUG

Placebo will be delivered orally 1 hour before anesthesia induction.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparoscopic hysterectomy to treat benign conditions.
• High risk for PONV according to the Apfel Score: scores 3 or 4.
• American Society of Anesthesiology (ASA) physical status: 1 or 2.

You may not qualify if:

• Cognitive or psychiatric conditions impairing consent or compliance.
• Incapability of using the mobile app MyCapp for data collection.
• History of allergy or sensibility to any medication included in the protocol: amisulpride, dexamethasone, ondansetron, fentanyl, midazolam, bupivacaine, morphine, propofol, rocuronium, sevoflurane, ephedrine, metaraminol, remifentanil, metamizole, ketoprofen, sugammadex, dimenhydrinate, pyridoxine hydrochloride, tramadol, dimethicone.
• Inability to swallow medications.
• Current use of typical or atypical antipsychotic medications.
• Gestation or lactation.
• Clinically significant cardiac arrhythmia or long QT syndrome documented.
• Hypokalemia (K+ \< 3.5 mmol/L)
• Prolactin-dependent tumors.
• Pheochromocytoma.
• Parkinson's disease.
• Nausea or vomiting in the 24 hours before surgery.
• Therapeutic use of antiemetics, including corticosteroids.
• Emetogenic oncological therapy (above 10% probability of causing vomiting) in the 2 weeks before surgery.
• Persistent pre-operative hypotension on the day of surgery, defined as systolic blood pressure \< 100 mmHg on at least 2 consecutive measurements.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Hospital da Mulher

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Vomiting; Postoperative Nausea and Vomiting

Interventions

Color; Weights and Measures; Smell

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Light; Optical Phenomena; Physical Phenomena; Investigative Techniques; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Angela M Sousa, MD, MsC, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natanael Pietroski dos Santos, MD

CONTACT

+55 11 963167080; pietroski@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MsC, PhD

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 20, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): March 29, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

BR (1)