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Completed

NCT Number: NCT02966041

Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting

To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation of post-operative sedation. In patients who have undergone open heart surgery, a single prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol sedation will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first 24 post-operative hours compared to placebo.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

About this study

Post-operative nausea and vomiting (PONV) is a significant source of morbidity for patients undergoing general anesthesia, and in particular, patients undergoing cardiac anesthesia. Despite its common occurrence, literature on PONV prophylaxis in the cardiac surgical population is limited relative to other surgical populations.

A rational approach to preventing PONV would be to administer prophylaxis prior to extubation once post-operative sedation has ceased. This timing of administration would be more standardized across patients, as duration of surgery and time of extubation after surgery can vary considerably, rendering plasma levels of PONV prophylaxis agents highly variable across patients.

At St. Paul's Hospital, PONV prophylaxis has not been a routine part of cardiac anesthesia care. Furthermore, there are no standardized guidelines, and practice varies between care providers. Following surgery, patients recover from anesthesia and are extubated in the cardiac surgery ICU (CSICU). They are usually sedated on a propofol infusion for one to four hours after surgery until they are ready for extubation. When PONV occurs, the first line drug for treatment is ondansetron 4 mg. The investigators therefore propose the use of a single, prophylactic dose of ondansetron (4 mg IV), given at the time of propofol cessation. A randomized, double blinded placebo controlled model will be utilized

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including:
  • Coronary artery bypass grafting (CABG)
  • Valve surgery (ie. repair and/or replacement)
  • CABG and valve surgery

Exclusion criteria

  • Undergoing 'off-pump' CABG (not involving the cardiopulmonary bypass machine)
  • With a contraindication to the study drug - including but not limited to congenital Long QT Syndrome, allergy to ondansetron, or a history of migraines
  • Unable to understand the consent process, either due to language limitations or cognitive limitations if a translator or substitute decision maker is not available
  • Receiving heart transplants, ventricular assist devices or on extra-corporeal membrane oxygenation (ECMO)
  • Intubated for more than 12 hours post-operatively
  • With a known history of PONV
  • Sedated with dexmedatomine instead of propofol

Treatment and study plan

ondansetron

Drug

Ondansetron/Zofran is an antiemetic drug used to prevent and treat nausea and vomiting.

Other names: Zofran

Saline

Drug

Normal saline is salt water and is acting as a placebo in this study. A placebo is an inactive substance that looks identical to the test drug, but it contains no therapeutic ingredient.

Other names: Placebo Comparator: Saline

Primary outcomes

  1. Occurrence of Post-operative Nausea and Vomiting (PONV)

    Time frame: First 24 hours post-extubation

    Measured by asking the patient hourly to assess their post operative nausea and vomiting using a 10-point verbal Likert rating scale.

Secondary outcomes

  1. Incidence of Rescue PONV medication administration

    Time frame: First 24 hours post-extubation

    How many participants received rescue post-operative nausea and vomiting medication post-extubation after surgery.

  2. Time to first dose of rescue PONV medication

    Time frame: First 24 hours post-extubation

    Time of administration of first dose of rescue post-operative nausea and vomiting medication

  3. Dose of any Rescue PONV medication

    Time frame: First 24 hours post-extubation

    Dose of administered rescue post-operative nausea and vomiting medication after extubation.

  4. Time to first report of nausea or first vomit post-operatively

    Time frame: First 24 hours post-extubation

    Time to first report of any nausea or vomiting after extubation post-operatively.

  5. Incidence of Post-operative nausea without vomiting

    Time frame: First 24 hours post-extubation

    Nurses both asked patients' for a nausea severity rating and recorded any vomiting hourly.

  6. Severity Post-operative nausea without vomiting

    Time frame: First 24 hours post-extubation

    Severity of post-operative nausea without vomiting based on a 10-point likert scale, recorded hourly.

  7. Incidence of ventricular arrhythmias

    Time frame: first 24 hours post-extubation

    Any sustained Ventricular Arrhythmias (i.e. lasting greater than 30 seconds)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

A Double-blinded, Randomized Control Trial of Prophylactic Ondansetron in a Post-operative Cardiac Surgery Population for Post-operative Nausea and Vomiting

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2016
Registry last updated
Oct 15, 2018

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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