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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of clinically important postoperative nausea and vomiting

Using the Postoperative Nausea and Vomiting Intensity Scale

Time frame
6h to 48h postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: