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

Hôpital Privé de Parly II - Le Chesnay

Status and phase: Completed; Phase 3

Conditions: Postoperative Vomiting; Postoperative Emesis; Postoperative Nausea

Treatments: Drug: Betamethasone; Drug: Droperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT02744495

2015-A01440-49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 2 patient groups

postoperative nausea and vomiting risk factors

Experimental group

Description:

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

Treatment:

Drug: Droperidol

Drug: Betamethasone

control

No Intervention group

Description:

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