Clinical trial NCT02744495: Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery
Official title: Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Vomiting
Postoperative Nausea
Postoperative Emesis
Keywords: cardiac surgery
corticoids
droperidol
antiemetics
Postoperative Vomiting
Postoperative Nausea
Postoperative Emesis
prophylaxis
Lead sponsor: Hôpital Privé de Parly II - Le Chesnay
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: postoperative nausea and vomiting
timeFrame: 48hour
Secondary outcomes:
measure: number of postoperative nausea and vomiting
timeFrame: 48hour
measure: postoperative nausea and vomiting (VAS)
timeFrame: 48hour
measure: postoperative pain (VAS)
timeFrame: 48hour
measure: postoperative discomfort (VAS)
timeFrame: 48hour
measure: Antiemetics (treatment)
timeFrame: 48hour
measure: Analgesics
timeFrame: 48hour
measure: Side effects
timeFrame: 48hour
measure: QTc interval
timeFrame: 48hour
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Parly2
Study officials:
References: