Back to resultsEffect of Ketamine on Analgesia Post-Cardiac Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Normal Saline Flush, 0.9% Injectable Solution_#1
Ketamine Hydrochloride
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Ketamine, Cardiac surgery, Pain
Eligibility Criteria
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
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Intraoperative infusion of ketamine
Control group receiving a saline infusion
Outcomes
Primary Outcome Measures
Quantity of Opioids Used in the First 48 Hours Postoperatively
Opioids used, in Dilaudid equivalents
Secondary Outcome Measures
Quantity of Opioids Used
Quantity in mg
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 Nausea and Vomiting
Whether or not the patient suffered from nausea and vomiting after surgery which required treatment
Intensive Care Unit Length of Stay
Number of days spent in the intensive care unit
Hospital Length of Stay
number of days spent in the hospital, starting from the day of surgery
Time to Extubation
Number of minutes from the time of ICU arrival to extubation
Delirium
Delirium as assessed by a positive CAM-ICU score during the ICU stay
Time to Mobilization
Time from ICU arrival until patient able to mobilize to chair, measured in hours
Time to Ambulation
Time from ICU arrival until patient able to ambulate, measured in hours
Full Information
NCT ID
NCT02925858
First Posted
October 4, 2016
Last Updated
August 6, 2019
Sponsor
Jewish General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02925858
Brief Title
Effect of Ketamine on Analgesia Post-Cardiac Surgery
Official Title
Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Ketamine, Cardiac surgery, Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intraoperative infusion of ketamine
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group receiving a saline infusion
Intervention Type
Drug
Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution_#1
Intervention Description
Normal saline infusion mimicking infusion rate of ketamine for a given weight
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
Primary Outcome Measure Information:
Title
Quantity of Opioids Used in the First 48 Hours Postoperatively
Description
Opioids used, in Dilaudid equivalents
Time Frame
First 48 hours after arrival to the ICU
Secondary Outcome Measure Information:
Title
Quantity of Opioids Used
Description
Quantity in mg
Time Frame
24 hours postoperatively
Title
Pain Scores (Visual Analog Scale)
Description
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)
Time Frame
Postoperative days 2
Title
Postoperative Nausea and Vomiting
Description
Whether or not the patient suffered from nausea and vomiting after surgery which required treatment
Time Frame
48 hours after ICU arrival
Title
Intensive Care Unit Length of Stay
Description
Number of days spent in the intensive care unit
Time Frame
1 day - 2 weeks
Title
Hospital Length of Stay
Description
number of days spent in the hospital, starting from the day of surgery
Time Frame
5 days - 2 weeks
Title
Time to Extubation
Description
Number of minutes from the time of ICU arrival to extubation
Time Frame
4 hours - 2 weeks
Title
Delirium
Description
Delirium as assessed by a positive CAM-ICU score during the ICU stay
Time Frame
ICU stay
Title
Time to Mobilization
Description
Time from ICU arrival until patient able to mobilize to chair, measured in hours
Time Frame
During hospital stay
Title
Time to Ambulation
Description
Time from ICU arrival until patient able to ambulate, measured in hours
Time Frame
1 week postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Cameron, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will provide all uncoded data
IPD Sharing Time Frame
Upon request, starting 6 months after publication
IPD Sharing Access Criteria
For planned meta-analyses
Learn more about this trial
Effect of Ketamine on Analgesia Post-Cardiac Surgery
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