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

Nausea and Vomiting, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013386
• Other study ID #: R 36 / 2019
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.