Nausea and Vomiting, PostoperativePhase 4NCT04013386
Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting
A Phase 4 study testing Aprepitant and Dexamethasone, Mirtazapine and Dexamethasone and Dexamethasone in people with Nausea and Vomiting, Postoperative, run by Ain Shams University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Aprepitant and Dexamethasone, Mirtazapine and Dexamethasone and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2019to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I or II
- Body mass index (BMI) ≥ 35 kg/cm-2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting After Laparoscopic Sleeve Surgery: a Randomized Controlled Trial
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.
Read the 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
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Aprepitant and Dexamethasone, Mirtazapine and Dexamethasone, Dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant and DexamethasoneDrug
Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI
Mirtazapine and DexamethasoneDrug
Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI
DexamethasoneDrug
Dexamethasone 8 mg IVI
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant/Dexamethasone Group | Active comparator | Not described Receives: Drug: Aprepitant and Dexamethasone |
| Mertazepine /Dexamethasone Group | Active comparator | Not described Receives: Drug: Mirtazapine and Dexamethasone |
| Dexamethasone Group | Active comparator | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery
Incidence (%) of nausea and vomiting in 24 hours(h) postoperative
Measured: First 24 hours(h) postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start15 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
- Investigators
- Tarek Mohamed Ashoor, MD, Study director, Faculty of Medicine, Ain- shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013386
- Sponsor's protocol ID
- R 36 / 2019
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35535050
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting After Laparoscopic Sleeve Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04013386
- Acronym / sponsor ID
- R 36 / 2019
- Conditions
- Nausea and Vomiting, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aprepitant/Dexamethasone Group | Active comparator | Drug: Aprepitant and Dexamethasone |
| Mertazepine /Dexamethasone Group | Active comparator | Drug: Mirtazapine and Dexamethasone |
| Dexamethasone Group | Active comparator | Drug: Dexamethasone |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I or II
- Body mass index (BMI) ≥ 35 kg/cm-2
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprepitant and DexamethasoneAprepitant capsule 80 mg and Dexamethasone 8 mg IVI | Drug | Aprepitant/Dexamethasone Group |
| Mirtazapine and DexamethasoneMirtazapine tablet 30 mg and Dexamethasone 8 mg IVI | Drug | Mertazepine /Dexamethasone Group |
| DexamethasoneDexamethasone 8 mg IVI | Drug | Dexamethasone Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Derived from this study: PubMed 35535050Ashoor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Mohamed Ashoor, MD study director
Faculty of Medicine, Ain- shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant and Dexamethasone, Mirtazapine and Dexamethasone and Dexamethasone in people with Nausea and Vomiting, Postoperative, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery (time frame: First 24 hours(h) postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.