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NCT02744495: PONVACS

Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)

Completed Phase 3 Last updated 13 December 2016
What this trial tests

Phase 3 trial testing Betamethasone in Postoperative Vomiting in 502 participants. Completed in 1 December 2016.

Timeline
1 February 2016
Primary endpoint
1 November 2016
1 December 2016

Quick facts

Lead sponsorHôpital Privé de Parly II - Le Chesnay
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment502
Start date1 February 2016
Primary completion1 November 2016
Estimated completion1 December 2016
Sites1 location across France

Drugs / interventions tested

Conditions studied

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.

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):

  1. 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
  2. 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:

Other trials of Betamethasone

Trials testing the same drug.

Other recruiting trials for Postoperative Vomiting

Currently open trials in the same condition.

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Data sources for this page

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