Postoperative VomitingPhase 3PONVACSNCT02744495
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery
A Phase 3 study testing Betamethasone and Droperidol in people with Postoperative Vomiting and Postoperative Nausea, run by Hôpital Privé de Parly II - Le Chesnay at 1 site in France.
Trial summary
To investigate the role of postoperative nausea and vomiting risk factors assessment after cardiac surgery. We designed a randomized controlled study comparing standard care (no risk factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting after cardiac surgery in high risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis
- What is being tested?
- Betamethasone and Droperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Dec 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non emergent cardiac surgery
- Age > 18 years
- Affiliation to French Social Security
- Approval of participation to the study
Who cannot join
- Pregnancy
- Contra indication to antiemetics
- Chronic usage of antiemetics
- Emergent or complicated surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)
To investigate the role of postoperative nausea and vomiting risk factors assessment after cardiac surgery. We designed a randomized controlled study comparing standard care (no risk factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors (if risk score is over 2) in the intervention arm.
Read the detailed description
Patients planned to undergo cardiac surgery were screened for inclusion. Inclusion criteria are as follow: Non emergent cardiac surgery; Age > 18 years; Affiliation to French Social Security; Approval of participation to the study; at the exclusion of: Pregnancy ; Contra indication to antiemetics; Chronic usage of antiemetics; and Emergent or complicated surgery.
Risk factors for postoperative nausea and vomiting were collected and patients were randomized by cluster into two arms.
Control: No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors were not available for practicians.
Intervention: Preoperative collection of postoperative nausea and vomiting risk factors available for practicians. Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.
All outcomes are assessed at 48 hours of surgery:
Primary: occurrence of postoperative nausea or vomiting Secondary: number of postoperative nausea and vomiting with visual assessment scale (VAS), and antiemetics used for treatment; postoperative pain (VAS) with number of analgesics used; postoperative discomfort (VAS).
Safety data: side effects and QT corrected intervals.
- Being tested
- Betamethasone, Droperidol
- Keywords
- cardiac surgery, corticoids, droperidol, antiemetics, Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis, prophylaxis
- 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.
BetamethasoneDrug
Also called Celestene
Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.
DroperidolDrug
Also called Droleptan
Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| postoperative nausea and vomiting risk factors | Experimental | Preoperative collection of postoperative nausea and vomiting risk factors available for practicians. Receives: Drug: Betamethasone; Drug: Droperidol |
| control | No intervention | No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
postoperative nausea and vomiting as a categorical variable
Measured: 48hour
Secondary outcomes (8)
number of postoperative nausea and vomiting
Measured: 48hour
postoperative nausea and vomiting (VAS)
Suffering from postoperative nausea and vomiting by visual assessment scale (VAS). VAS is a 100 point scale: 0 indicate absence of nausea or vomiting; 100 indicate maximal nausea and vomiting
Measured: 48hour
postoperative pain (VAS)
VAS is a 100 point scale: 0 indicate absence of pain; 100 indicate maximal pain
Measured: 48hour
postoperative discomfort (VAS)
VAS is a 100 point scale: 0 indicate absence of discomfort; 100 indicate maximal discomfort
Measured: 48hour
Antiemetics (treatment)
Number of antiemetics used as a treatment for postoperative nausea or vomiting
Measured: 48hour
Analgesics
Number of Analgesics used at 48h
Measured: 48hour
Side effects
Measured: 48hour
QTc interval
Pre and postoperative QTc (corrected) intervals
Measured: 48hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé de Parly II - Le Chesnay
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sébastien CHAMPION, Hôpital Privé de Parly II - Le Chesnay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744495
- Sponsor's protocol ID
- 2015-A01440-49
- Acronym
- PONVACS
- Status last verified
- Dec 2016
- First submitted
- 8 Apr 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: On demand
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)
- ClinicalTrials.gov ID
- NCT02744495
- Acronym / sponsor ID
- PONVACS / 2015-A01440-49
- Keywords
- cardiac surgery, corticoids, droperidol, antiemetics, Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis, prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Hôpital Privé de Parly II - Le ChesnayUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Apr 2016 (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.
To investigate the role of postoperative nausea and vomiting risk factors assessment after cardiac surgery. We designed a randomized controlled study comparing standard care (no risk factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors (if risk score is over 2) in the intervention arm.
Detailed description
Patients planned to undergo cardiac surgery were screened for inclusion. Inclusion criteria are as follow: Non emergent cardiac surgery; Age > 18 years; Affiliation to French Social Security; Approval of participation to the study; at the exclusion of: Pregnancy ; Contra indication to antiemetics; Chronic usage of antiemetics; and Emergent or complicated surgery.
Risk factors for postoperative nausea and vomiting were collected and patients were randomized by cluster into two arms.
Control: No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors were not available for practicians.
Intervention: Preoperative collection of postoperative nausea and vomiting risk factors available for practicians. Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.
All outcomes are assessed at 48 hours of surgery:
Primary: occurrence of postoperative nausea or vomiting Secondary: number of postoperative nausea and vomiting with visual assessment scale (VAS), and antiemetics used for treatment; postoperative pain (VAS) with number of analgesics used; postoperative discomfort (VAS).
Safety data: side effects and QT corrected intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative nausea and vomiting risk factors | Experimental | Drug: Betamethasone, Drug: DroperidolPreoperative collection of postoperative nausea and vomiting risk factors available for practicians. |
| control | No intervention | –No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non emergent cardiac surgery
- Age > 18 years
- Affiliation to French Social Security
- Approval of participation to the study
Key exclusion criteria (4 listed)
- Pregnancy
- Contra indication to antiemetics
- Chronic usage of antiemetics
- Emergent or complicated 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 |
|---|---|---|
| BetamethasoneAlso: CelesteneProphylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm. | Drug | postoperative nausea and vomiting risk factors |
| DroperidolAlso: DroleptanProphylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm. | Drug | postoperative nausea and vomiting risk factors |
Primary outcome
postoperative nausea and vomiting
Time frame: 48hour
postoperative nausea and vomiting as a categorical variable
8 secondary outcomes
number of postoperative nausea and vomiting
Time frame: 48hour
postoperative nausea and vomiting (VAS)
Time frame: 48hour
postoperative pain (VAS)
Time frame: 48hour
postoperative discomfort (VAS)
Time frame: 48hour
Antiemetics (treatment)
Time frame: 48hour
Analgesics
Time frame: 48hour
Side effects
Time frame: 48hour
QTc interval
Time frame: 48hour
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 14 Dec 2016.
- Individual participant dataSharing planned: Yes. On demand
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Betamethasone and Droperidol in people with Postoperative Vomiting and Postoperative Nausea, run by Hôpital Privé de Parly II - Le Chesnay at 1 site in France.
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 4 inclusion and 4 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 14 Dec 2016. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
postoperative nausea and vomiting (time frame: 48hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2016.