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Multimodal Analgesia in Cardiac Surgery (Pilot Study)

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ClinicalTrials.gov Identifier: NCT02734940
Recruitment Status : Terminated (Unable to find participants who met inclusion/exclusion criteria)
First Posted : April 12, 2016
Results First Posted : February 19, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The investigators objective is to assess the effectiveness of an opioid sparing multimodal approach for enhancing the recovery in Cardiac Surgical patients. This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.

Condition or disease Intervention/treatment Phase
Heart Diseases Drug: Lidocaine Drug: Unrestricted Fentanyl Drug: Ketamine Drug: Precedex Drug: Duramorph Phase 4

Detailed Description:

Cardiac surgery is associated with significant acute pain and a proportion of these patients will develop chronic pain.

Opioids are the main stay of analgesia in cardiac surgery because of the safer hemodynamic profile and sedation. However high dose narcotic use is associated with a variety of unwanted side effects prolonging postoperative recovery. There is growing evidence for the effectiveness of multimodal approach utilizing opiate sparing techniques for enhancing patient recovery following surgery. Early extubation has been associated with improved patient outcome and cost effectiveness in cardiac surgery. The investigators objective is to assess the effectiveness of an opioid sparing multimodal approach for enhancing the recovery in Cardiac Surgical patients. This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. All of the above anesthetic drugs have opioid sparing effect in surgical Patients.

Dexmedetomidine use has been associated with decreased cardiac arrhythmias and improved neurological outcome in cardiac surgical patients. Ketamine has been linked with attenuation of postoperative cognitive dysfunction after cardiac surgery. Both intravenous lidocaine and spinal morphine have been shown to reduce opioid consumption in the perioperative period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Analgesia in Cardiac Surgery (Pilot Study)
Actual Study Start Date : July 11, 2016
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Unrestricted Fentanyl

Will receive injection of sterile saline (2cc) in lower back area (to minimize participant bias) and unrestricted amount of intraoperative opioids (fentanyl) at the discretion of the Anesthesiologist.

Both groups will receive General Anesthesia with volatile agents and single dose of iv Tylenol intraoperatively. Both groups of patients will be transported to Intensive Care Unit (ICU) on Dexmedetomidine (dose range 0.25 - 0.7 mcg/kg/hr). Dose titration is based on sedation level and hemodynamic goals set by Cardiac Anesthesiologist.

Drug: Unrestricted Fentanyl
No changes to current practices, using unlimited narcotic medications intraoperatively.
Other Name: Unlimited intraoperative opiates

Experimental: Lidocaine, Dexmedetomidine and Ketamine
Will receive pre-operative spinal duramorph (4mcg/kg up to max dose of 300mcg), intra-operative intravenous (iv) infusion of Ketamine (0.4 mg/kg/hr), Lidocaine (20 mcg/kg/min) and Dexmedetomidine (0.25 mcg/kg/hr) started after induction of General Anesthesia and maintained through the Cardiopulmonary Bypass (CPB) towards the end of surgery. At this point all infusions will be turned off except Dexmedetomidine. The total intraoperative fentanyl dose will be limited to <250mcg (or 3mcg/kg) and total midazolam to ≤ 2mg in the study group.
Drug: Lidocaine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Other Name: IV Lidocaine

Drug: Ketamine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.

Drug: Precedex
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Other Name: IV Precedex

Drug: Duramorph
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Other Name: Spinal Duramorph




Primary Outcome Measures :
  1. Pain Scores - Numerical Rating Scale, 0-10 [ Time Frame: 24 hours ]
    Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)


Secondary Outcome Measures :
  1. Postoperative Opioid Consumption [ Time Frame: 24 hours, 48 hours, 72 hours ]
    Opioid consumption measured in oral morphine equivalents

  2. Patient Satisfaction [ Time Frame: 24 hours, 48 hours, 72 hours, 7 days, 30 days ]
    Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded)

  3. Extubation [ Time Frame: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours) ]
    Time from arrival to ICU to extubation

  4. ICU Length of Stay [ Time Frame: Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days) ]
  5. Delirium Scores [ Time Frame: 24, 48 and 72 hours ]
    CAM-ICU scores at above time points

  6. Ionotropic Requirement [ Time Frame: Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days) ]
    Total amount ionotropes required

  7. Bowel Function [ Time Frame: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days) ]
    Bowel Function

  8. Ionotropic Requirement [ Time Frame: Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days) ]
    Total duration of ionotropic requirement (hours)



Information from the National Library of Medicine

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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:

  • Elective CABGs and/or Valve replacements, ≥ 18 years old

Exclusion Criteria:

  • Re-do cardiac surgery, Acute endocarditis, Circulatory arrest, Emergent cases, Shock, Left Ventricular Assist Device, Transplantation, Transcatheter Aortic Valve Replacement, contraindications for Spinal including coagulopathy and Clopidogrel <7days, psychosis, known allergy to any of the study drugs, Preoperative liver dysfunction (AST/ALT > 2 times normal) and Renal dysfunction (Cr > 2 mg/dL), inability to administer spinal anesthetic, preoperative opioid use, patients who are unable to give their own consent, expected prolonged intubation postoperatively (>12 hrs), prisoners, pregnancy

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): NCT02734940


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Praveen Prasanna, MD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02734940    
Other Study ID Numbers: HM20004692
First Posted: April 12, 2016    Key Record Dates
Results First Posted: February 19, 2018
Last Update Posted: August 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Lidocaine
Fentanyl
Ketamine
Dexmedetomidine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Hypnotics and Sedatives
Analgesics, Non-Narcotic