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NCT Number: NCT02744495

Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

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.

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Key information

Conditions

Postoperative Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Emesis Postoperative Nausea Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Parly2

Le Chesnay, 78150, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone

Drug

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

Droperidol

Drug

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

Primary outcomes

  1. postoperative nausea and vomiting

    Time frame: 48hour

    postoperative nausea and vomiting as a categorical variable

Secondary outcomes

  1. number of postoperative nausea and vomiting

    Time frame: 48hour

  2. 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

  3. postoperative pain (VAS)

    Time frame: 48hour

    VAS is a 100 point scale: 0 indicate absence of pain; 100 indicate maximal pain

  4. postoperative discomfort (VAS)

    Time frame: 48hour

    VAS is a 100 point scale: 0 indicate absence of discomfort; 100 indicate maximal discomfort

  5. Antiemetics (treatment)

    Time frame: 48hour

    Number of antiemetics used as a treatment for postoperative nausea or vomiting

  6. Analgesics

    Time frame: 48hour

    Number of Analgesics used at 48h

  7. Side effects

    Time frame: 48hour

  8. QTc interval

    Time frame: 48hour

    Pre and postoperative QTc (corrected) intervals

Sponsors and collaborators

Lead sponsor

Hôpital Privé de Parly II - Le Chesnay

Other

Registry information

Official study title

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

Acronym: PONVACS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2016
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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