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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04013386

Enrollment

Registered

2019-07-09

Start date

2019-07-15

Completion date

2019-12-31

Last updated

2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Postoperative

Brief 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.

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

DRUGAprepitant and Dexamethasone

Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI

DRUGMirtazapine and Dexamethasone

Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI

DRUGDexamethasone

Dexamethasone 8 mg IVI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026