Effect of Ketamine on Analgesia Post-Cardiac Surgery

Ketamine

Brief Summary

Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.

Intervention / Treatment

  • Normal Saline Flush, 0.9% Injectable Solution_#1 (DRUG)
    Normal saline infusion mimicking infusion rate of ketamine for a given weight
  • Ketamine Hydrochloride (DRUG)
    Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)

Condition or Disease

  • Pain, Postoperative

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 28, 2017 ACTUAL
    Primary Completion: Nov 01, 2018 ACTUAL
    Completion Date: Nov 27, 2018 ACTUAL
    Study First Posted: Oct 06, 2016 ESTIMATED
    Results First Posted: Sep 06, 2019 ACTUAL
    Last Updated: Aug 06, 2019

    Sponsors / Collaborators

    Lead Sponsor: Jewish General Hospital
    Responsible Party: N/A

    Location

    Montreal, Quebec, Canada

    This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome

    Participant Groups

    • Intraoperative infusion of ketamine

    • Control group receiving a saline infusion

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery

    Exclusion Criteria:

    * Minimally invasive cardiac surgery
    * Preoperative opioid use
    * Preoperative hepatic or renal dysfunction

    Primary Outcomes

    • Opioids used, in Dilaudid equivalents

    Secondary Outcomes

    • Quantity in mg

    • Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)

    • Whether or not the patient suffered from nausea and vomiting after surgery which required treatment

    • Number of days spent in the intensive care unit

    • number of days spent in the hospital, starting from the day of surgery

    • Number of minutes from the time of ICU arrival to extubation

    • Delirium as assessed by a positive CAM-ICU score during the ICU stay

    • Time from ICU arrival until patient able to mobilize to chair, measured in hours

    • Time from ICU arrival until patient able to ambulate, measured in hours

    More Details

    NCT Number: NCT02925858
    Other IDs: 16-289
    Study URL: https://clinicaltrials.gov/study/NCT02925858
    Last updated: Sep 29, 2023