Clinical trial NCT02734940: Multimodal Analgesia in Cardiac Surgery (Pilot Study)
Official title: Multimodal Analgesia in Cardiac Surgery (Pilot Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Diseases
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain Scores - Numerical Rating Scale, 0-10
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative Opioid Consumption
timeFrame: 24 hours, 48 hours, 72 hours
measure: Patient Satisfaction
timeFrame: 24 hours, 48 hours, 72 hours, 7 days, 30 days
measure: Extubation
timeFrame: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
measure: ICU Length of Stay
timeFrame: Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)
measure: Delirium Scores
timeFrame: 24, 48 and 72 hours
measure: Ionotropic Requirement
timeFrame: Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days)
measure: Bowel Function
timeFrame: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
measure: Ionotropic Requirement
timeFrame: Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Praveen Prasanna, MD
role: PRINCIPAL_INVESTIGATOR
References: