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Effect of Ketamine on Analgesia Post-Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02925858
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Cameron, Jewish General Hospital

Tracking Information
First Submitted Date  ICMJE October 4, 2016
First Posted Date  ICMJE October 6, 2016
Results First Submitted Date  ICMJE March 1, 2019
Results First Posted Date  ICMJE September 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE August 28, 2017
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
Quantity of opioids used in the first 48 hours postoperatively [ Time Frame: First 48 hours postoperatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Quantity of Opioids Used [ Time Frame: 24 hours postoperatively ]
    Quantity in mg
  • 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)
  • 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
  • Intensive Care Unit Length of Stay [ Time Frame: 1 day - 2 weeks ]
    Number of days spent in the intensive care unit
  • Hospital Length of Stay [ Time Frame: 5 days - 2 weeks ]
    number of days spent in the hospital, starting from the day of surgery
  • Time to Extubation [ Time Frame: 4 hours - 2 weeks ]
    Number of minutes from the time of ICU arrival to extubation
  • Delirium [ Time Frame: ICU stay ]
    Delirium as assessed by a positive CAM-ICU score during the ICU stay
  • Time to Mobilization [ Time Frame: During hospital stay ]
    Time from ICU arrival until patient able to mobilize to chair, measured in hours
  • Time to Ambulation [ Time Frame: 1 week postoperatively ]
    Time from ICU arrival until patient able to ambulate, measured in hours
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • Quantity of opioids used in the first 24 hours postoperatively [ Time Frame: First 24 hours postoperatively ]
  • Postoperative pain score on 10-point visual analog scale [ Time Frame: 24 and 48 hours postoperatively ]
  • Postoperative nausea and vomiting [ Time Frame: 48 hours postoperatively ]
  • Intensive care unit length of stay [ Time Frame: 1 day - 2 weeks ]
  • Hospital length of stay [ Time Frame: 5 days - 2 weeks ]
  • Time to extubation [ Time Frame: 4 hours - 2 weeks ]
  • Blood products received in first 48 hours [ Time Frame: 48 hours postoperatively ]
  • Reported nightmares or hallucinations [ Time Frame: 48 hours postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ketamine on Analgesia Post-Cardiac Surgery
Official Title  ICMJE Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: Normal Saline Flush, 0.9% Injectable Solution_#1
    Normal saline infusion mimicking infusion rate of ketamine for a given weight
  • Drug: Ketamine Hydrochloride
    Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
Study Arms  ICMJE
  • Experimental: Intervention
    Intraoperative infusion of ketamine
    Intervention: Drug: Ketamine Hydrochloride
  • Placebo Comparator: Control
    Control group receiving a saline infusion
    Intervention: Drug: Normal Saline Flush, 0.9% Injectable Solution_#1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 27, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02925858
Other Study ID Numbers  ICMJE 16-289
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Will provide all uncoded data
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Upon request, starting 6 months after publication
Access Criteria: For planned meta-analyses
Responsible Party Matthew Cameron, Jewish General Hospital
Study Sponsor  ICMJE Jewish General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Cameron, MD Jewish General Hospital
PRS Account Jewish General Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP