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

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Begins enrollment this month; Phase 3

Conditions: Prevention; Nausea and Vomiting, Postoperative

Treatments: Drug: Placebo; Drug: Aprepitant 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07248280

2026-13145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups, including a placebo group

Aprepitant

Experimental group

Description:

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

Treatment:

Drug: Aprepitant 40mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo