NCT02744495

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

9 months

First QC Date

April 8, 2016

Last Update Submit

December 13, 2016

Conditions

Postoperative VomitingPostoperative NauseaPostoperative Emesis

Keywords

cardiac surgerycorticoidsdroperidolantiemeticsPostoperative VomitingPostoperative NauseaPostoperative Emesisprophylaxis

Outcome Measures

Primary Outcomes (1)

  • postoperative nausea and vomiting

    postoperative nausea and vomiting as a categorical variable

    48hour

Secondary Outcomes (8)

  • number of postoperative nausea and vomiting

    48hour

  • postoperative nausea and vomiting (VAS)

    48hour

  • postoperative pain (VAS)

    48hour

  • postoperative discomfort (VAS)

    48hour

  • Antiemetics (treatment)

    48hour

  • +3 more secondary outcomes

Study Arms (2)

postoperative nausea and vomiting risk factors

EXPERIMENTAL

Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.

Drug: BetamethasoneDrug: Droperidol

control

NO INTERVENTION

No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians.

Interventions

BetamethasoneDRUG

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.

Also known as: Celestene
postoperative nausea and vomiting risk factors
DroperidolDRUG

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.

Also known as: Droleptan
postoperative nausea and vomiting risk factors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non emergent cardiac surgery
  • Age \> 18 years
  • Affiliation to French Social Security
  • Approval of participation to the study

You may not qualify if:

  • Pregnancy
  • Contra indication to antiemetics
  • Chronic usage of antiemetics
  • Emergent or complicated surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parly2

Le Chesnay, 78150, France

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

BetamethasoneDroperidol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedButyrophenonesKetonesOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 20, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 14, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

On demand

Locations

FR(1)