PONVACS: Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

Sponsor

Hôpital Privé de Parly II - Le Chesnay (Other)

Overall Status

Completed

CT.gov ID

NCT02744495

Collaborator

(none)

502

Enrollment

Location

Arms

Duration (Months)

50.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Vomiting Postoperative Nausea Postoperative Emesis	Drug: Betamethasone Drug: Droperidol	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

502 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: postoperative nausea and vomiting risk factors Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.	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
No Intervention: control No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians.

Arm

Intervention/Treatment

Experimental: postoperative nausea and vomiting risk factors

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

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

Other Names:

Droleptan

No Intervention: control

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

Outcome Measures

Primary Outcome Measures

postoperative nausea and vomiting [48hour]
postoperative nausea and vomiting as a categorical variable

Secondary Outcome Measures

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