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

NCT02966041 | Completed DMC

• 1 other identifier: H15-00675
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting; PONV; CSICU; post-cardiac surgery; cardiac intensive care unit

Outcome Measures

Primary Outcomes (1)

• Occurrence of Post-operative Nausea and Vomiting (PONV)

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

  First 24 hours post-extubation

Secondary Outcomes (7)

• Incidence of Rescue PONV medication administration

  First 24 hours post-extubation

• Time to first dose of rescue PONV medication

  First 24 hours post-extubation

• Dose of any Rescue PONV medication

  First 24 hours post-extubation

• Time to first report of nausea or first vomit post-operatively

  First 24 hours post-extubation

• Incidence of Post-operative nausea without vomiting

  First 24 hours post-extubation

Study Arms (2)

Ondansetron

EXPERIMENTAL

Ondansetron 4mg IV at time of discontinuation of Propofol Infusion

Drug: Ondansetron

Saline

PLACEBO COMPARATOR

2 mL IV Normal Saline at time of discontinuation of Propofol Infusion

Drug: Saline

Interventions

Ondansetron DRUG

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

Also known as: Zofran

Ondansetron

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.

Also known as: Placebo Comparator: Saline

Saline

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

• Wang EHZ, Sunderland S, Edwards NY, Chima NS, Yarnold CH, Schwarz SKW, Coley MA. A Single Prophylactic Dose of Ondansetron Given at Cessation of Postoperative Propofol Sedation Decreases Postoperative Nausea and Vomiting in Cardiac Surgery Patients: A Randomized Controlled Trial. Anesth Analg. 2020 Oct;131(4):1164-1172. doi: 10.1213/ANE.0000000000004730.

  PMID: 32925337 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Matthew Coley, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Erica Wang, PharmD

  University of British Columbia

  STUDY CHAIR

• Cynthia Yarnold, MD

  University of British Columbia

  STUDY CHAIR

• Stephan Schwarz, MD

  University of British Columbia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 17, 2016
• Study Start: March 6, 2018
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CA (1)