Aprepitant to Mitigate Opioids' Cognitive Side Effects

Study Overview
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Brief Summary
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Morphine and similar substances (called opioids) are often prescribed for moderate to severe pain, such as after a surgery, thus allowing for minimal pain and a better recovery. Unfortunately various, non-dangerous side effects from opioids occur often that limit the way patients feel and can take of themselves, despite otherwise good pain control and minimal limitations from the surgery itself.

Detailed Description
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In this proposed study the investigators want to examine if the drug aprepitant can decrease the so called cognitive impairments opioids may cause, such as drowsiness, loopiness and feeling high. This would allow for a better recovery period, in which patients can be more themselves, participate in activities around them and move forward. Subjects scheduled for elective surgeries with expected opioid medication for moderate to severe pain and good functional status shortly after surgery will be randomized to receive either aprepitant or placebo shortly before their surgery and for two more days thereafter. A telephone interview for cognitive status and several specific questions will be used to assess the effect of aprepitant on the subjects' cognitive and functional status.

Official Title
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Aprepitant to Mitigate Opioids' Cognitive Side Effects

Conditions
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Cognitive Dysfunction

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy English speaking, opioid-naive consenting adults Exclusion Criteria: current or very recent (< 3 months) opioid therapy morbid obesity liver disease therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists (warfarin), hormonal contraceptives acute or chronic infections immunocompromised status hemodynamically unstable, hemorrhage (bleeding) recent surgery pregnancy, nursing younger than 18 years old not proficient of the English language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aprepitant<br>Aprepitant 40 mg IV pre-operatively 40 mg PO post-op day #1 40 mg PO post-op day #2 | Drug: Aprepitant<br>* 3 days perioperative Aprepitant once a day<br>* Other names: Emend;|
| Placebo Comparator: Placebo<br>electrolyte (0.9% NaCl) infusion) pre-operatively capsule without medication on post-op day #1 capsule without medication on post-op day #2 | Drug: Placebo<br>* 3 days perioperative Placebot once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function | questionnaires | 3 days post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drowsiness, loopiness, nausea