Multimodal Analgesia in Cardiac Surgery (Pilot Study)

NCT02734940 | Terminated Phase 4 Results

• 1 other identifier: HM20004692
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Pain Scores - Numerical Rating Scale, 0-10

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

  24 hours

Secondary Outcomes (8)

• Postoperative Opioid Consumption

  24 hours, 48 hours, 72 hours

• Patient Satisfaction

  24 hours, 48 hours, 72 hours, 7 days, 30 days

• Extubation

  Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)

• ICU Length of Stay

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

• Delirium Scores

  24, 48 and 72 hours

Study Arms (2)

Unrestricted Fentanyl

ACTIVE COMPARATOR

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

Lidocaine, Dexmedetomidine and Ketamine

EXPERIMENTAL

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; Drug: Ketamine; Drug: Precedex; Drug: Duramorph

Interventions

Lidocaine DRUG

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

Also known as: IV Lidocaine

Lidocaine, Dexmedetomidine and Ketamine

Unrestricted Fentanyl DRUG

No changes to current practices, using unlimited narcotic medications intraoperatively.

Also known as: Unlimited intraoperative opiates

Unrestricted Fentanyl

Ketamine DRUG

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

Lidocaine, Dexmedetomidine and Ketamine

Precedex DRUG

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

Also known as: IV Precedex

Lidocaine, Dexmedetomidine and Ketamine

Duramorph DRUG

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

Also known as: Spinal Duramorph

Lidocaine, Dexmedetomidine and Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Lidocaine; Ketamine; Dexmedetomidine; Morphine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Jessica Potter
• Organization: Virginia Commonwealth University

jessica.potter@vcuhealth.org

(804) 828-2755

Study Officials

• Praveen Prasanna, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 12, 2016
• Study Start: July 11, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 7, 2018
• Results First Posted: February 19, 2018

Record last verified: 2018-07

Locations

US (1)