Postoperative Nausea and VomitingPhase 4PONVNCT02357693
Neurokinin Receptor Antagonist Associated to Ondansetron in PONV
A Phase 4 study testing Aprepitant in people with Postoperative Nausea and Vomiting, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Aug 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high risk patients for nausea and vomiting
Who cannot join
- cardiovascular disease, or hypersensibility to any of the drugs involved in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Association of Neurokinin-1 Receptor Antagonist Aprepitant to Dexamethasone/Ondansetron in the Incidence of Postoperative Nausea and Vomiting in High Risk Apfel Score Patients
The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.
Read the detailed description
High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Aprepitant
- Keywords
- nausea, postoperative, postoperative nausea, postoperative vomiting, vomiting, postoperative
- 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.
AprepitantDrug
Also called Emend
Aprepitant or placebo will be administered to the patient before surgery
| Study group | Role | What they receive |
|---|---|---|
| aprepitant | Experimental | aprepitant 80 mg one hour before surgery Receives: Drug: Aprepitant |
| placebo | Placebo comparator | oral placebo one hour before surgery Receives: Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nausea and vomiting in postoperative period
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
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 Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- 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
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazem a Ashmawi, phD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357693
- Sponsor's protocol ID
- CEP 280/12
- Acronym
- PONV
- Status last verified
- Aug 2015
- First submitted
- 31 Jan 2015
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kawano H, Matsumoto T, Hamaguchi E, Manabe S, Nakagawa M, Yamada A, Fujimoto M, Tada F. Antiemetic efficacy of combined aprepitant and dexamethasone in patients at high-risk of postoperative nausea and vomiting from epidural fentanyl analgesia. Minerva Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.
PubMed 25220550
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Association of Neurokinin-1 Receptor Antagonist Aprepitant to Dexamethasone/Ondansetron in the Incidence of Postoperative Nausea and Vomiting in High Risk Apfel Score Patients
- ClinicalTrials.gov ID
- NCT02357693
- Acronym / sponsor ID
- PONV / CEP 280/12
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- nausea, postoperative, postoperative nausea, postoperative vomiting, vomiting, postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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.
The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.
Detailed description
High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aprepitant | Experimental | Drug: Aprepitantaprepitant 80 mg one hour before surgery |
| placebo | Placebo comparator | Drug: Aprepitantoral placebo one hour before surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high risk patients for nausea and vomiting
Key exclusion criteria (1 listed)
- cardiovascular disease, or hypersensibility to any of the drugs involved in the study
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 |
|---|---|---|
| AprepitantAlso: EmendAprepitant or placebo will be administered to the patient before surgery | Drug | aprepitant, placebo |
Primary outcome
Incidence of nausea and vomiting in postoperative period
Time frame: 24 hours
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 25 Aug 2015.
- Results publication: PubMed 25220550Kawano H, Matsumoto T, Hamaguchi E, Manabe S, Nakagawa M, Yamada A, Fujimoto M, Tada F. Antiemetic efficacy of combined aprepitant and dexamethasone in patients at high-risk of postoperative nausea and vomiting from epidural fentanyl analgesia. Minerva Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.
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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.
Hazem a Ashmawi, phD study director
University of Sao Paulo
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 in people with Postoperative Nausea and Vomiting, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 25 Aug 2015. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Incidence of nausea and vomiting in postoperative period (time frame: 24 hours). 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 NCT02357693, 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 25 Aug 2015.