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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 31, 2019

Detailed Description

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

Interventions

  • Drug: Aprepitant and Dexamethasone
    • Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI
  • Drug: Mirtazapine and Dexamethasone
    • Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI
  • Drug: Dexamethasone
    • Dexamethasone 8 mg IVI

Arms, Groups and Cohorts

  • Active Comparator: Aprepitant/Dexamethasone Group
  • Active Comparator: Mertazepine /Dexamethasone Group
  • Active Comparator: Dexamethasone Group

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt. – Ain Shams University
  • Overall Official(s)
    • Tarek Mohamed Ashoor, MD, Study Director, Faculty of Medicine, Ain- shams University

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