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

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase: Begins enrollment in 3 months; Phase 4

Conditions: Otologic Disease

Treatments: Other: Placebo; Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT07371728

2026-4646

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Description:

Oral aprepitant 80mg within an hour of induction

Treatment:

Drug: Aprepitant

Control Arm

Placebo Comparator group

Description:

Placebo capsule within an hour of induction

Treatment:

Other: Placebo