Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery

NCT07371728 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026-4646
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.

Conditions

Otologic Disease

Keywords

aprepitant; nausea; vomiting; otologic surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically important postoperative nausea and vomiting

  Using the Postoperative Nausea and Vomiting Intensity Scale

  6h to 48h postoperatively

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Oral aprepitant 80mg within an hour of induction

Drug: Aprepitant

Control Arm

PLACEBO COMPARATOR

Placebo capsule within an hour of induction

Other: Placebo

Interventions

Aprepitant DRUG

Participants will be randomly assigned to the intervention or control group in a 1:1 ratio. Oral aprepitant of 80mg will be administered within an hour of induction for an otological surgery.

Treatment Arm

Placebo OTHER

Participants will be randomly assigned to the intervention or control group in a 1:1 ratio. An oral placebo capsule will be administered within an hour of induction for an otological surgery.

Control Arm

Eligibility Criteria

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

You may qualify if:

• Adult patients undergoing middle ear surgery including tympanoplasty with or without ossicular chain reconstruction, tympanomastoidectomy or stapedectomy
• Patient using a hormonal contraceptive will be included, but warned aprepitant may reduce the efficacy of hormonal contraception thus an alternative or backup contraceptive methods should be used for one month after surgery

You may not qualify if:

• Children (\<18 years old)
• Patients unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)
• Patients taking concomitant medications that are substrates, inhibitors or inducers of CYP3A4 or CYP2CP that are at risk of having a clinically significant effect
• Patients with a history of hypersensitivity reaction to any of the medications used in the study
• Patients who are pregnant or breastfeeding
• Patients unable to receive general anesthesia (i.e. procedures performed under local anesthesia with or without sedation)
• Patients with severe hepatic insufficiency (Child-Pugh class C)
• Patients on total intravenous anesthesia (TIVA)

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Ear Diseases; Nausea; Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Emily Ajit-Roger, MD

CONTACT

514 340-7581; emily.ajit-roger@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngologist

Model Details: A randomized, double-blind placebo-controlled trial will be conducted at a single academic institution (Jewish General Hospital) after approval from the Research Ethics Board.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 28, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)