About this trial
This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Aprepitant
DrugParticipants 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.
Placebo
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of clinically important postoperative nausea and vomiting
Using the Postoperative Nausea and Vomiting Intensity Scale
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: