Trial | NCT02744495  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    502
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.
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.
Study Started
Feb 29
2016
Primary Completion
Nov 30
2016
Study Completion
Dec 31
2016
Last Update
Dec 14
2016
Estimate

Drug 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.

  • Other names: Celestene

Drug 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 names: Droleptan

postoperative nausea and vomiting risk factors Experimental

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

control No Intervention

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

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
No Results Posted