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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

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Normal Saline Flush, 0.9% Injectable Solution_#1 Drug: Ketamine Hydrochloride Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain
Actual Study Start Date : August 28, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Intervention
Intraoperative infusion of ketamine
Drug: Ketamine Hydrochloride
Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)

Placebo Comparator: Control
Control group receiving a saline infusion
Drug: Normal Saline Flush, 0.9% Injectable Solution_#1
Normal saline infusion mimicking infusion rate of ketamine for a given weight




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925858


Locations
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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Jewish General Hospital
Investigators
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Principal Investigator: Matthew Cameron, MD Jewish General Hospital
  Study Documents (Full-Text)

Documents provided by Matthew Cameron, Jewish General Hospital:

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Responsible Party: Matthew Cameron, Assistant Professor, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02925858     History of Changes
Other Study ID Numbers: 16-289
First Posted: October 6, 2016    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will provide all uncoded data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Upon request, starting 6 months after publication
Access Criteria: For planned meta-analyses

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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
Keywords provided by Matthew Cameron, Jewish General Hospital:
Ketamine
Cardiac surgery
Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action