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

Primary Purpose

Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Betamethasone
Droperidol
Sponsored by
Hôpital Privé de Parly II - Le Chesnay
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Vomiting focused on measuring cardiac surgery, corticoids, droperidol, antiemetics, Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis, prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Parly2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

postoperative nausea and vomiting risk factors

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative nausea and vomiting
postoperative nausea and vomiting as a categorical variable

Secondary Outcome Measures

number of postoperative nausea and vomiting
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
postoperative pain (VAS)
VAS is a 100 point scale: 0 indicate absence of pain; 100 indicate maximal pain
postoperative discomfort (VAS)
VAS is a 100 point scale: 0 indicate absence of discomfort; 100 indicate maximal discomfort
Antiemetics (treatment)
Number of antiemetics used as a treatment for postoperative nausea or vomiting
Analgesics
Number of Analgesics used at 48h
Side effects
QTc interval
Pre and postoperative QTc (corrected) intervals

Full Information

First Posted
April 8, 2016
Last Updated
December 13, 2016
Sponsor
Hôpital Privé de Parly II - Le Chesnay
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1. Study Identification

Unique Protocol Identification Number
NCT02744495
Brief Title
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery
Acronym
PONVACS
Official Title
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Privé de Parly II - Le Chesnay

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis
Keywords
cardiac surgery, corticoids, droperidol, antiemetics, Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis, prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
postoperative nausea and vomiting risk factors
Arm Type
Experimental
Arm Description
Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.
Arm Title
control
Arm Type
No Intervention
Arm Description
No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians.
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Other Intervention Name(s)
Celestene
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Droperidol
Other Intervention Name(s)
Droleptan
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting
Description
postoperative nausea and vomiting as a categorical variable
Time Frame
48hour
Secondary Outcome Measure Information:
Title
number of postoperative nausea and vomiting
Time Frame
48hour
Title
postoperative nausea and vomiting (VAS)
Description
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
Time Frame
48hour
Title
postoperative pain (VAS)
Description
VAS is a 100 point scale: 0 indicate absence of pain; 100 indicate maximal pain
Time Frame
48hour
Title
postoperative discomfort (VAS)
Description
VAS is a 100 point scale: 0 indicate absence of discomfort; 100 indicate maximal discomfort
Time Frame
48hour
Title
Antiemetics (treatment)
Description
Number of antiemetics used as a treatment for postoperative nausea or vomiting
Time Frame
48hour
Title
Analgesics
Description
Number of Analgesics used at 48h
Time Frame
48hour
Title
Side effects
Time Frame
48hour
Title
QTc interval
Description
Pre and postoperative QTc (corrected) intervals
Time Frame
48hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non emergent cardiac surgery Age > 18 years Affiliation to French Social Security Approval of participation to the study Exclusion Criteria: Pregnancy Contra indication to antiemetics Chronic usage of antiemetics Emergent or complicated surgery
Facility Information:
Facility Name
Parly2
City
Le Chesnay
ZIP/Postal Code
78150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On demand

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Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

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