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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2019-12-31

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.

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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

Conditions

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Nausea and Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Aprepitant/Dexamethasone Group

Group Type ACTIVE_COMPARATOR

Aprepitant and Dexamethasone

Intervention Type DRUG

Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI

Mertazepine /Dexamethasone Group

Group Type ACTIVE_COMPARATOR

Mirtazapine and Dexamethasone

Intervention Type DRUG

Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI

Dexamethasone Group

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 8 mg IVI

Interventions

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Aprepitant and Dexamethasone

Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI

Intervention Type DRUG

Mirtazapine and Dexamethasone

Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI

Intervention Type DRUG

Dexamethasone

Dexamethasone 8 mg IVI

Intervention Type DRUG

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No