Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries

Study Overview
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Brief Summary
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The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.

Detailed Description
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Postoperative Nausea and Vomiting (PONV) is a serious and common (50%-70%) complication of laparoscopic abdominal surgery. PONV is multifactorial, and the treatment is multimodal. Preoperative treatment should target the specific mechanism of PONV to minimize its incidence/consequences to the benefit of the patients. Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P.5 Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response. Dexamethasone is an inexpensive and effective antiemetic drug with minimal side effects after a single-dose administration. The commonly used minimal effective dose is 8 to 10 mg, but the dose 5 mg is suggested for PONV in patients undergoing laparoscopic surgeries. Based on the literature review, occurrence of PONV does not significantly differ at dosing of Dexamethasone equal or higher than 4 mg. This study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant and dexamethasone or aprepitant alone preoperatively.

Official Title
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A Randomized, Double-Blind Comparison of Oral Aprepitant and Lower Dose Dexamethasone vs Aprepitant Alone for Preventing Postoperative Nausea and Vomiting After Elective Laparoscopic Surgeries

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Aprepitant
* Drug: Placebo Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years old ASA physical status I-III must have at least 2 risk factors for PONV Exclusion Criteria: pregnant or breast feeding patients antiemetic medication in previous 24 hours allergy or other contraindication to study medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br>Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting | Drug: Dexamethasone<br>* Dexamethasone 5 mg administered intravenously following endotracheal intubation<br>* Other names: EMEND;Drug: Aprepitant<br>* Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia<br>* Other names: EMEND;|
| Placebo Comparator: Placebo Comparator<br>Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting | Drug: Aprepitant<br>* Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia<br>* Other names: EMEND;Drug: Placebo Dexamethasone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidences of nausea, vomiting, need for rescue medication |  | 1 hour, 2 hours, 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidences of unplanned hospital admission; duration of PACU stay |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic, Surgery, Postoperative, Nausea, Vomiting, Aprepitant, Dexamethasone, Postoperative Nausea, Postoperative Vomiting