Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 3, 2020
December 1, 2019
6 months
July 5, 2019
December 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
Aprepitant/Dexamethasone Group
ACTIVE COMPARATORMertazepine /Dexamethasone Group
ACTIVE COMPARATORDexamethasone Group
ACTIVE COMPARATORInterventions
Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI
Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI
Eligibility Criteria
You may qualify if:
- ASA physical status I or II
- Body mass index (BMI) ≥ 35 kg/cm-2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain-Shams University Hospitals
Cairo, Egypt
Related Publications (1)
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.
PMID: 35535050DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tarek Mohamed Ashoor, MD
Faculty of Medicine, Ain- shams University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 9, 2019
Study Start
July 15, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
January 3, 2020
Record last verified: 2019-12