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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
502
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.
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.
Parly2
Le Chesnay, France
postoperative nausea and vomiting
postoperative nausea and vomiting as a categorical variable
Time frame: 48hour
number of postoperative nausea and vomiting
Time frame: 48hour
postoperative nausea and vomiting (VAS)
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
Time frame: 48hour
postoperative pain (VAS)
VAS is a 100 point scale: 0 indicate absence of pain; 100 indicate maximal pain
Time frame: 48hour
postoperative discomfort (VAS)
VAS is a 100 point scale: 0 indicate absence of discomfort; 100 indicate maximal discomfort
Time frame: 48hour
Antiemetics (treatment)
Number of antiemetics used as a treatment for postoperative nausea or vomiting
Time frame: 48hour
Analgesics
Number of Analgesics used at 48h
Time frame: 48hour
Side effects
Time frame: 48hour
QTc interval
Pre and postoperative QTc (corrected) intervals
Time frame: 48hour
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