Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis

Intervention / Treatment
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* Drug: Betamethasone
* Drug: Droperidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: postoperative nausea and vomiting risk factors<br>Preoperative collection of postoperative nausea and vomiting risk factors available for practicians. | Drug: Betamethasone<br>* 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.<br>* Other names: Celestene;Drug: Droperidol<br>* 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.<br>* Other names: Droleptan;|
| No Intervention: control<br>No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea and vomiting | postoperative nausea and vomiting as a categorical variable | 48hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, corticoids, droperidol, antiemetics, Postoperative Vomiting, Postoperative Nausea, Postoperative Emesis, prophylaxis