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

NCT ID: NCT07248280

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-24
• Study Completion Date: 2027-01-01

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.

Detailed Description

Postoperative nausea and vomiting (PONV) are common and debilitating complications that can occur after surgery. Their incidence is estimated to be around 30% in the general population and may reach up to 80% in high-risk patients in the absence of prevention, thus constituting a frequent and major source of dissatisfaction. In outpatient surgery, it is still assumed that postoperative outcomes are straightforward. However, this perception is based on a bias of ignorance, as postoperative outcomes are rarely measured after hospital discharge. However, recent studies suggest that nearly 40% of patients may present with PONV once at home. The symptoms are sometimes considered more debilitating than the postoperative pain itself. Although rarely serious, they have a considerable impact on patient satisfaction and the length of their recovery. In some studies, they even represent the main cause of readmission after outpatient surgery or failure of discharge, resulting in additional costs for the healthcare system.

This study aims to evaluate if the addition of 40 mg aprepitant to a multimodal strategy for preventing post operative nausea and vomitting improves clinical outcomes in high-risk patients undergoing outpatient surgery.

The primary objective of this study is to evaluate the complete response rate, defined as the absence of nausea, vomiting, or the need for rescue treatment within 48 hours following surgery.

Conditions

Nausea and Vomiting, Postoperative; Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Aprepitant

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

Group Type: EXPERIMENTAL

Aprepitant 40mg

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Aprepitant 40mg

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 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).

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxim Roy, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Maxim Roy, MD, FRCPC

Role: CONTACT

maxim.roy.med@ssss.gouv.qc.ca

514-890-8000 ext. 12132

Vicky Thiffault, BSN

Role: CONTACT

anesthesie.recherche.chum@ssss.gouv.qc.ca

514-890-8000 ext. 24542

Facility Contacts

Vicky Thiffault, RN

Role: primary

anesthesie.recherche.chum@ssss.gouv.qc.ca

514-890-8000 ext. 24542

Other Identifiers

2026-13145

Identifier Type: -

Identifier Source: org_study_id