Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery
NCT ID: NCT02744495
Last Updated: 2016-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
502 participants
INTERVENTIONAL
2016-02-29
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
postoperative nausea and vomiting risk factors
Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.
Betamethasone
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.
Droperidol
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.
control
No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Betamethasone
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.
Droperidol
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age \> 18 years
* Affiliation to French Social Security
* Approval of participation to the study
Exclusion Criteria
* Contra indication to antiemetics
* Chronic usage of antiemetics
* Emergent or complicated surgery
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hôpital Privé de Parly II - Le Chesnay
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sébastien CHAMPION
Dr
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parly2
Le Chesnay, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-A01440-49
Identifier Type: -
Identifier Source: org_study_id