Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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Laparoscopic sleeve gastrectomy (LSG) is an emerging treatment modality among the various types of surgical approach to obesity (1). The incidence of PONV in obese patients undergoing bariatric surgery, who did not receive antiemetic prophylaxis, is high at nearly 70-80 % (2,3). Postoperatively, bariatric patients appear to suffer from nausea and vomiting more frequently than normal weight or obese patients.

Detailed Description
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Currently, available interventions for PONV prophylaxis, especially as monotherapy, lack universal efficacy. Use of combination therapies with different pharmacological basis is likely to bring down rates of PONV. (6) Intravenous dexamethasone (8-10mg) reduces the incidence of PONV, minimizing activity of phospholipase A2 and blocking the expression of cyclooxygenase (COX)2 mRNA that reduce production of prostaglandin and control the release of endorphins. Aprepitant has demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV), and in the prevention of postoperative nausea and vomiting (PONV) The use of mirtazapine in the management of nausea and vomiting has been reported for both treatment and premedication

Official Title
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Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting After Laparoscopic Sleeve Surgery: a Randomized Controlled Trial

Conditions
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Nausea and Vomiting, Postoperative

Intervention / Treatment
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* Drug: Aprepitant and Dexamethasone
* Drug: Mirtazapine and Dexamethasone
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I or II Body mass index (BMI) ≥ 35 kg/cm-2 Exclusion Criteria: Patients with gastrointestinal disorders, Patients with significant major organ disease, Patients received antidepressant drugs, Patients received an anti-emetic drug within 48 h before surgery, Patients on treatment with systemic glucocorticoids within 4 weeks before surgery.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 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: Aprepitant/Dexamethasone Group<br> | Drug: Aprepitant and Dexamethasone<br>* Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI<br>|
| Active Comparator: Mertazepine /Dexamethasone Group<br> | Drug: Mirtazapine and Dexamethasone<br>* Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI<br>|
| Active Comparator: Dexamethasone Group<br> | Drug: Dexamethasone<br>* Dexamethasone 8 mg IVI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery | Incidence (%) of nausea and vomiting in 24 hours(h) postoperative | First 24 hours(h) postoperative. |