NCT07248280

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2026-02-27
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2025-11-25
• Last updated: 2026-03-03

Locations

1 site across 1 country: Canada