Otologic DiseasePhase 4NCT07371728
Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery
A Phase 4 study testing Aprepitant in people with Otologic Disease, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial summary
This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otologic Disease
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Emily Ajit-Roger, MD, 514 340-7581, emily.ajit-roger@mail.mcgill.ca
About this study
Official title: Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery: A Pilot Randomized-Controlled Trial
This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.
Read the detailed description
Post-operative nausea and vomiting (PONV) is one of the most common post-surgical complications and is associated with prolonged hospital stays, higher readmission rates, and heightened physical and emotional burden on patients and their families. While the general incidence of PONV is reported to be approximately 20-30% across all specialties, it may affect up to 60-80% of patients undergoing middle ear surgery. Indeed, surgical drilling and irrigation close to inner ear structures may stimulate the vestibular system and activate the chemoreceptor trigger zone and emetic center.
Aprepitant is a novel selective neurokinin-1 (NK1) antagonist which has been extensively studied for the prevention of chemotherapy-induced nausea and vomiting. Randomized controlled trials in gynecologic and open abdominal surgery have shown pre-operative oral aprepitant may provide benefit in reducing nausea and vomiting in the post-operative setting, even beyond commonly employed anti-emetics such as 5HT3 receptor antagonists4. While some authors have reported on its use in thyroid, facial plastics and transsphenoidal surgery, no trial to date has specifically investigated the use of pre-operative aprepitant as an adjunctive medication to reduce post-operative nausea and vomiting in patients undergoing middle ear surgery.
The hypothesis of this research project is that pre-operative aprepitant will provide the added benefit in reducing the incidence of post-operative nausea and vomiting in patients undergoing middle ear surgery when administered in conjunction with a 5-HT3 antagonist and dexamethasone.
- Conditions
- Otologic Disease
- Being tested
- Aprepitant, Placebo
- Keywords
- aprepitant, nausea, vomiting, otologic surgery
- Medical subject headings
- Ear Diseases, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Oral aprepitant 80mg within an hour of induction Receives: Drug: Aprepitant |
| Control Arm | Placebo comparator | Placebo capsule within an hour of induction Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically important postoperative nausea and vomiting
Using the Postoperative Nausea and Vomiting Intensity Scale
Measured: 6h to 48h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Kay-Rivest, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371728
- Sponsor's protocol ID
- 2026-4646
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery: A Pilot Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT07371728
- Acronym / sponsor ID
- 2026-4646
- Conditions
- Otologic Disease
- Keywords
- aprepitant, nausea, vomiting, otologic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.
Detailed description
Post-operative nausea and vomiting (PONV) is one of the most common post-surgical complications and is associated with prolonged hospital stays, higher readmission rates, and heightened physical and emotional burden on patients and their families. While the general incidence of PONV is reported to be approximately 20-30% across all specialties, it may affect up to 60-80% of patients undergoing middle ear surgery. Indeed, surgical drilling and irrigation close to inner ear structures may stimulate the vestibular system and activate the chemoreceptor trigger zone and emetic center.
Aprepitant is a novel selective neurokinin-1 (NK1) antagonist which has been extensively studied for the prevention of chemotherapy-induced nausea and vomiting. Randomized controlled trials in gynecologic and open abdominal surgery have shown pre-operative oral aprepitant may provide benefit in reducing nausea and vomiting in the post-operative setting, even beyond commonly employed anti-emetics such as 5HT3 receptor antagonists4. While some authors have reported on its use in thyroid, facial plastics and transsphenoidal surgery, no trial to date has specifically investigated the use of pre-operative aprepitant as an adjunctive medication to reduce post-operative nausea and vomiting in patients undergoing middle ear surgery.
The hypothesis of this research project is that pre-operative aprepitant will provide the added benefit in reducing the incidence of post-operative nausea and vomiting in patients undergoing middle ear surgery when administered in conjunction with a 5-HT3 antagonist and dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AprepitantOral aprepitant 80mg within an hour of induction |
| Control Arm | Placebo comparator | Other: PlaceboPlacebo capsule within an hour of induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantParticipants 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. | Drug | Treatment Arm |
| PlaceboParticipants 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. | Other | Control Arm |
Primary outcome
Incidence of clinically important postoperative nausea and vomiting
Time frame: 6h to 48h postoperatively
Using the Postoperative Nausea and Vomiting Intensity Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
Related trials for Otologic Disease
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant in people with Otologic Disease, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Ajit-Roger, MD (514 340-7581, emily.ajit-roger@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically important postoperative nausea and vomiting (time frame: 6h to 48h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.