Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
NCT Number: NCT07371728
This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Montreal, Quebec, H3T 1E2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6h to 48h postoperatively
Using the Postoperative Nausea and Vomiting Intensity Scale
Contact information is provided by the study sponsor or research team.
Sir Mortimer B. Davis - Jewish General Hospital
Other
Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery: A Pilot Randomized-Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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