Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

Overview

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.

Full Title of Study: “Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: postoperative nausea and vomiting risk factors
    • Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.
  • No Intervention: control
    • No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians.

Clinical Trial Outcome Measures

Primary Measures

  • postoperative nausea and vomiting
    • Time Frame: 48hour
    • postoperative nausea and vomiting as a categorical variable

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hôpital Privé de Parly II – Le Chesnay
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sébastien CHAMPION, Dr – Hôpital Privé de Parly II – Le Chesnay

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