NCT02744495

Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Hôpital Privé de Parly II - Le Chesnay · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Vomiting
• Postoperative Nausea
• Postoperative Emesis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2016-04-20
• Last updated: 2016-12-14

Locations

1 site across 1 country: France