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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea; Postoperative Vomiting; Postoperative Emesis
• Intervention / Treatment: Drug: Betamethasone; Drug: Droperidol

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 Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • Parly2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hôpital Privé de Parly II - Le Chesnay

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (ESTIMATE): April 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: cardiac surgery; prophylaxis; Postoperative Nausea; Postoperative Vomiting; antiemetics; corticoids; droperidol; Postoperative Emesis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adjuvants, Anesthesia; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Droperidol
• Other Study ID Numbers: 2015-A01440-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On demand