Adding Aprepitant to a Multimodal Strategy for the Prevention of Postoperative Nausea and Vomiting in High-risk Outpatient Surgical Patients

NCT07248280 | Recruiting Phase 3

• 1 other identifier: 2026-13145
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative nausea and vomiting (PONV) are a frequent and debilitating complications after surgery, affecting up to 80% of patients at high risk in the absence of prophylaxis. Despite the rigorous application of the recommendations from the American Society of Anesthesiologists (ASA) at CHUM, a recent local study reveals a prevalence of 25% PONV at home after outpatient surgery. However, the therapeutic options at home remain limited. This study aims to evaluate if the addition of 40 mg aprepitant to a multimodal strategy for preventing PONV improves clinical outcomes in high-risk patients undergoing outpatient surgery.

Conditions

Nausea and Vomiting, Postoperative; Prevention

Keywords

Ambulatory care; Aprepitant

Outcome Measures

Primary Outcomes (1)

• Rate of complete response according to postoperative nausea and vomitting

  The rate of 'complete response' (CR), defined as the proportion of patients who experienced no episodes of postoperative nausea or vomiting (PONV) and did not require rescue medication following the addition of 40mg of aprepitant to a multimodal prevention strategy for PONV in high-risk patients during the first 48 hours following surgery.

  48 hours after the surgery

Secondary Outcomes (6)

• Severity and frequence of nausea and vomiting

  At discharge from recovery room, usually 1h after the end of the surgery, 24 hours and 48 hours after the surgery

• Medical economic impact

  48 hours after the surgery

• Quality of recovery

  Change between baseline (before surgery) and 48 hours after the surgery

• Incidence of side effects

  48 hours after the surgery

• Patient satisfaction

  48 hours after the surgery

Study Arms (2)

Aprepitant

EXPERIMENTAL

Participants will receive a 40 mg capsule of aprepitant, in addition to standard antiemetic prophylaxis.

Drug: Aprepitant 40mg

Placebo

PLACEBO COMPARATOR

Participants will receive a 40 mg capsule of placebo, in addition to standard antiemetic prophylaxis

Drug: Placebo

Interventions

Aprepitant 40mg DRUG

Just before the patient is taken to the operating room, a single oral capsule of 40 mg of aprepitant will be given to the participant to evaluate the effectiveness of 40 mg of aprepitant in preventing postoperative nausea and vomiting (PONV) in outpatient surgery. The protocol was chosen to determine whether adding aprepitant to a standard multimodal strategy provides a clinically measurable benefit compared to placebo.

Aprepitant

Placebo DRUG

Just before the patient is taken to the operating room, a single oral capsule of 40 mg of placebo will be given to the participant.

Placebo

Eligibility Criteria

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

You may qualify if:

• years and over, requiring an ambulatory surgery
• at high risk of post-operative nausea and vomitting defined by at least 3 factors from the Apfel score, calculated just prior to the surgery (female sex; non smoker; previous nausea or vomitting post-op., or motion sickness; expected opioid consumption in postoperative care).

You may not qualify if:

• Refusal or unable to consent
• Suspected or documented allergy to aprepitant (emend)
• Concomitant use of medication interacting via the cytochrome CYP3A4 with aprepitant (pimozide, terfenadine, astemizole, comtadin or cisapride).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Maxim Roy, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxim Roy, MD, FRCPC

CONTACT

514-890-8000; maxim.roy.med@ssss.gouv.qc.ca

Vicky Thiffault, BSN

CONTACT

514-890-8000; anesthesie.recherche.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, phase III superiority clinical trial conducted in parallel groups with triple blinding

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)