Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

Phase 3

Completed

• Conditions: Postoperative Emesis; Postoperative Vomiting; Postoperative Nausea
• Interventions: Drug: Betamethasone; Drug: Droperidol

• Registration Number: NCT02744495
• Lead Sponsor: Hôpital Privé de Parly II - Le Chesnay

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Primary Completion: 2016-11
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postoperative nausea and vomiting risk factors	Betamethasone	Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.
postoperative nausea and vomiting risk factors	Droperidol	Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.

Primary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	48hour	postoperative nausea and vomiting as a categorical variable

Secondary Outcome Measures

Name	Time	Method
Side effects	48hour
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
QTc interval	48hour	Pre and postoperative QTc (corrected) intervals

Trial Locations

Locations (1)

Parly2; 🇫🇷 Le Chesnay, France