Effect of Ketamine on Analgesia Post-Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Normal Saline Flush, 0.9% Injectable Solution_#1
* Drug: Ketamine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intraoperative infusion of ketamine | Drug: Ketamine Hydrochloride<br>* Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)<br>|
| Placebo Comparator: Control<br>Control group receiving a saline infusion | Drug: Normal Saline Flush, 0.9% Injectable Solution_#1<br>* Normal saline infusion mimicking infusion rate of ketamine for a given weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of Opioids Used in the First 48 Hours Postoperatively | Opioids used, in Dilaudid equivalents | First 48 hours after arrival to the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of Opioids Used | Quantity in mg | 24 hours postoperatively | 
| Pain Scores (Visual Analog Scale) | 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) | Postoperative days 2 | 
| Postoperative Nausea and Vomiting | Whether or not the patient suffered from nausea and vomiting after surgery which required treatment | 48 hours after ICU arrival | 
| Intensive Care Unit Length of Stay | Number of days spent in the intensive care unit | 1 day - 2 weeks | 
| Hospital Length of Stay | number of days spent in the hospital, starting from the day of surgery | 5 days - 2 weeks | 
| Time to Extubation | Number of minutes from the time of ICU arrival to extubation | 4 hours - 2 weeks | 
| Delirium | Delirium as assessed by a positive CAM-ICU score during the ICU stay | ICU stay | 
| Time to Mobilization | Time from ICU arrival until patient able to mobilize to chair, measured in hours | During hospital stay | 
| Time to Ambulation | Time from ICU arrival until patient able to ambulate, measured in hours | 1 week postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Cardiac surgery, Pain