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NCT02744495: PONVACS
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)
Phase 3 trial testing Betamethasone in Postoperative Vomiting in 502 participants. Completed in 1 December 2016.
1 November 2016
Quick facts
| Lead sponsor | Hôpital Privé de Parly II - Le Chesnay |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 502 |
| Start date | 1 February 2016 |
| Primary completion | 1 November 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across France |
Drugs / interventions tested
- Betamethasone (BETAMETHASONE) — full drug profile →
- Droperidol (DROPERIDOL) — full drug profile →
Conditions studied
- Postoperative Vomiting — all drugs for Postoperative Vomiting →
- Postoperative Nausea — all drugs for Postoperative Nausea →
- Postoperative Emesis — all drugs for Postoperative Emesis →
Sponsor
Hôpital Privé de Parly II - Le Chesnay
Who can join
18 and older, any sex, with Postoperative Vomiting or Postoperative Nausea. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
postoperative nausea and vomiting
Time frame: 48hour
postoperative nausea and vomiting as a categorical variable
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.
Weibel S, Rücker G, Eberhart LH, Pace NL, et al · · 2020 · cited 125× · PMID 33075160 · DOI 10.1002/14651858.cd012859.pub2 -
Prophylaxis of postoperative nausea and vomiting after cardiac surgery in high-risk patients: A randomized controlled study.
Champion S, Zieger L, Hemery C. · · 2018 · cited 21× · PMID 29336385 · DOI 10.4103/aca.aca_122_17
Verify or expand the search:
- PubMed search for NCT02744495
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Betamethasone
Trials testing the same drug.
- NCT06786689 — To Compare the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate t · Phase 2 · completed
- NCT07297264 — Betamethasone and Complications of Lower Third Molar Surgery · Phase 3 · terminated
- NCT04900220 — Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections · Phase 4 · completed
- NCT03210545 — A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT) · Phase 4 · completed
- NCT03702959 — Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia · unknown
Other recruiting trials for Postoperative Vomiting
Currently open trials in the same condition.
- NCT06753500 — Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy · Phase 4 · recruiting
- NCT06305221 — Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Rec · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02744495 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hôpital Privé de Parly II - Le Chesnay
- Last refreshed: 13 December 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02744495.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing