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

Primary Purpose

Nausea and Vomiting, Postoperative

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Aprepitant and Dexamethasone

Mirtazapine and Dexamethasone

Dexamethasone

About this trial

This is an interventional prevention trial for Nausea and Vomiting, Postoperative

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Ain-Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Aprepitant/Dexamethasone Group

Mertazepine /Dexamethasone Group

Dexamethasone Group

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery

Incidence (%) of nausea and vomiting in 24 hours(h) postoperative

Secondary Outcome Measures

Full Information

NCT ID

NCT04013386

First Posted

July 5, 2019

Last Updated

December 31, 2019

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04013386

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea and Vomiting, Postoperative

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aprepitant/Dexamethasone Group

Arm Type

Active Comparator

Arm Title

Mertazepine /Dexamethasone Group

Arm Type

Active Comparator

Arm Title

Dexamethasone Group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Aprepitant and Dexamethasone

Intervention Description

Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI

Intervention Type

Drug

Intervention Name(s)

Mirtazapine and Dexamethasone

Intervention Description

Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone 8 mg IVI

Primary Outcome Measure Information:

Title

Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery

Description

Incidence (%) of nausea and vomiting in 24 hours(h) postoperative

Time Frame

First 24 hours(h) postoperative.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tarek Mohamed Ashoor, MD

Organizational Affiliation

Faculty of Medicine, Ain- shams University

Official's Role

Study Director

Facility Information:

Facility Name

Ain-Shams University Hospitals

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

35535050

Citation

Ashoor TM, Kassim DY, Esmat IM. A Randomized Controlled Trial for Prevention of Postoperative Nausea and Vomiting after Laparoscopic Sleeve Gastrectomy: Aprepitant/Dexamethasone vs. Mirtazapine/Dexamethasone. Anesthesiol Res Pract. 2022 Apr 30;2022:3541073. doi: 10.1155/2022/3541073. eCollection 2022.

Results Reference

derived

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

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