Heart Diseases
Conditions
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.
Interventions
DRUGLidocaine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
DRUGUnrestricted Fentanyl
No changes to current practices, using unlimited narcotic medications intraoperatively.
DRUGKetamine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
DRUGPrecedex
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
DRUGDuramorph
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores - Numerical Rating Scale, 0-10 | 24 hours | Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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 | Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours) | 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) | — |
| Postoperative Opioid Consumption | 24 hours, 48 hours, 72 hours | Opioid consumption measured in oral morphine equivalents |
| Ionotropic Requirement | 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 | Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days) | Bowel Function |
| Delirium Scores | 24, 48 and 72 hours | CAM-ICU scores at above time points |
Countries
United States
Participant flow
Recruitment details
The study was terminated because of lack of enrollment. No data was ever collected.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Unrestricted Fentanyl: No changes to current practices, using unlimited narcotic medications intraoperatively. | 0 |
| 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. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pain Scores - Numerical Rating Scale, 0-10
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
Time frame: 24 hours
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
Bowel Function
Bowel Function
Time frame: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
Delirium Scores
CAM-ICU scores at above time points
Time frame: 24, 48 and 72 hours
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
Extubation
Time from arrival to ICU to extubation
Time frame: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
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)
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
Ionotropic Requirement
Total amount ionotropes required
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)
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
Ionotropic Requirement
Total duration of ionotropic requirement (hours)
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)
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
Patient Satisfaction
Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded)
Time frame: 24 hours, 48 hours, 72 hours, 7 days, 30 days
Population: The study was terminated because of lack of enrollment. No data was collected.
Secondary
Postoperative Opioid Consumption
Opioid consumption measured in oral morphine equivalents
Time frame: 24 hours, 48 hours, 72 hours
Population: The study was terminated because of lack of enrollment. No data was collected.