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NCT Number: NCT02925858

Effect of Ketamine on Analgesia Post-Cardiac Surgery

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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)

Primary outcomes

  1. Quantity of Opioids Used in the First 48 Hours Postoperatively

    Time frame: First 48 hours after arrival to the ICU

    Opioids used, in Dilaudid equivalents

Secondary outcomes

  1. Quantity of Opioids Used

    Time frame: 24 hours postoperatively

    Quantity in mg

  2. Pain Scores (Visual Analog Scale)

    Time frame: Postoperative days 2

    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)

  3. Postoperative Nausea and Vomiting

    Time frame: 48 hours after ICU arrival

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

  4. Intensive Care Unit Length of Stay

    Time frame: 1 day - 2 weeks

    Number of days spent in the intensive care unit

  5. Hospital Length of Stay

    Time frame: 5 days - 2 weeks

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

  6. Time to Extubation

    Time frame: 4 hours - 2 weeks

    Number of minutes from the time of ICU arrival to extubation

  7. Delirium

    Time frame: ICU stay

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

  8. Time to Mobilization

    Time frame: During hospital stay

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

  9. Time to Ambulation

    Time frame: 1 week postoperatively

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

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
Sep 6, 2019

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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