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NCT Number: NCT04013386

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

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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Key information

Conditions

Nausea and Vomiting, Postoperative Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant and Dexamethasone

Drug

Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI

Mirtazapine and Dexamethasone

Drug

Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI

Dexamethasone

Drug

Dexamethasone 8 mg IVI

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2019
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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