Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multimodal Analgesia in Cardiac Surgery (Pilot Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 9, 2016
First Posted Date  ICMJE April 12, 2016
Results First Submitted Date  ICMJE January 22, 2018
Results First Posted Date  ICMJE February 19, 2018
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE July 11, 2016
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Postoperative Opioid Consumption [ Time Frame: 24 hours, 48 hours, 72 hours ]
    Opioid consumption measured in oral morphine equivalents
  • 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)
  • Extubation [ Time Frame: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours) ]
    Time from arrival to ICU to extubation
  • 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) ]
  • Delirium Scores [ Time Frame: 24, 48 and 72 hours ]
    CAM-ICU scores at above time points
  • 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
  • Bowel Function [ Time Frame: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days) ]
    Bowel Function
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • Postoperative Opioid Consumption [ Time Frame: 24 hours, 48 hours, 72 hours ]
    Opioid consumption measured in oral morphine equivalents
  • 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)
  • Extubation [ Time Frame: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours) ]
    Time from arrival to ICU to extubation
  • 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) ]
  • Delirium Scores [ Time Frame: 24, 48 and 72 hours ]
    CAM-ICU scores at above time points
  • 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
  • Bowel Function [ Time Frame: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days) ]
    Bowel Function
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Analgesia in Cardiac Surgery (Pilot Study)
Official Title  ICMJE Multimodal Analgesia in Cardiac Surgery (Pilot Study)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Diseases
Intervention  ICMJE
  • Drug: Lidocaine
    This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
    Other Name: IV Lidocaine
  • Drug: Unrestricted Fentanyl
    No changes to current practices, using unlimited narcotic medications intraoperatively.
    Other Name: Unlimited intraoperative opiates
  • 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
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Unrestricted Fentanyl
  • 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.
    Interventions:
    • Drug: Lidocaine
    • Drug: Ketamine
    • Drug: Precedex
    • Drug: Duramorph
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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 1, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2016)
50
Actual Study Completion Date  ICMJE February 1, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02734940
Other Study ID Numbers  ICMJE HM20004692
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Praveen Prasanna, MD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date July 2018

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