Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Ketamine

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.

Intervention / Treatment

  • Lidocaine (DRUG)
    This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
  • Unrestricted Fentanyl (DRUG)
    No changes to current practices, using unlimited narcotic medications intraoperatively.
  • Ketamine (DRUG)
    This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
  • Precedex (DRUG)
    This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
  • Duramorph (DRUG)
    This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.

Condition or Disease

  • Heart Diseases

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 3 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 11, 2016 ACTUAL
    Primary Completion: Feb 01, 2017 ACTUAL
    Completion Date: Feb 01, 2017 ACTUAL
    Study First Posted: Apr 12, 2016 ESTIMATED
    Results First Posted: Feb 19, 2018 ACTUAL
    Last Updated: Jul 09, 2018

    Sponsors / Collaborators

    Lead Sponsor: Virginia Commonwealth University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Richmond, Virginia, USA

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)

    Secondary Outcomes

    • Opioid consumption measured in oral morphine equivalents

    • Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded)

    • Time from arrival to ICU to extubation

    • ICU Length of Stay Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)

    • CAM-ICU scores at above time points

    • Total amount ionotropes required

    • Bowel Function

    • Total duration of ionotropic requirement (hours)

    More Details

    NCT Number: NCT02734940
    Other IDs: HM20004692
    Study URL: https://clinicaltrials.gov/study/NCT02734940
    Last updated: Sep 29, 2023