Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

Postoperative Nausea Clinical Trial

— PONVACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744495
• Other study ID #: 2015-A01440-49
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2016
• Last updated: December 13, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Hôpital Privé de Parly II - Le Chesnay
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament (ANSM)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Emesis
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Parly2	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Privé de Parly II - Le Chesnay

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative nausea and vomiting	postoperative nausea and vomiting as a categorical variable	48hour	No
Secondary	number of postoperative nausea and vomiting		48hour	No
Secondary	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	No
Secondary	postoperative pain (VAS)	VAS is a 100 point scale: 0 indicate absence of pain; 100 indicate maximal pain	48hour	No
Secondary	postoperative discomfort (VAS)	VAS is a 100 point scale: 0 indicate absence of discomfort; 100 indicate maximal discomfort	48hour	No
Secondary	Antiemetics (treatment)	Number of antiemetics used as a treatment for postoperative nausea or vomiting	48hour	No
Secondary	Analgesics	Number of Analgesics used at 48h	48hour	No
Secondary	Side effects		48hour	Yes
Secondary	QTc interval	Pre and postoperative QTc (corrected) intervals	48hour	Yes