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Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Primary Purpose

Heart Diseases

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Unrestricted Fentanyl
Ketamine
Precedex
Duramorph
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Unrestricted Fentanyl

Lidocaine, Dexmedetomidine and Ketamine

Arm Description

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.

Outcomes

Primary Outcome Measures

Pain Scores - Numerical Rating Scale, 0-10
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)

Secondary Outcome Measures

Postoperative Opioid Consumption
Opioid consumption measured in oral morphine equivalents
Patient Satisfaction
Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded)
Extubation
Time from arrival to ICU to extubation
ICU Length of Stay
Delirium Scores
CAM-ICU scores at above time points
Ionotropic Requirement
Total amount ionotropes required
Bowel Function
Bowel Function
Ionotropic Requirement
Total duration of ionotropic requirement (hours)

Full Information

First Posted
March 9, 2016
Last Updated
July 9, 2018
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02734940
Brief Title
Multimodal Analgesia in Cardiac Surgery (Pilot Study)
Official Title
Multimodal Analgesia in Cardiac Surgery (Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to find participants who met inclusion/exclusion criteria
Study Start Date
July 11, 2016 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unrestricted Fentanyl
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lidocaine, Dexmedetomidine and Ketamine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
IV Lidocaine
Intervention Description
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Intervention Type
Drug
Intervention Name(s)
Unrestricted Fentanyl
Other Intervention Name(s)
Unlimited intraoperative opiates
Intervention Description
No changes to current practices, using unlimited narcotic medications intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Intervention Type
Drug
Intervention Name(s)
Precedex
Other Intervention Name(s)
IV Precedex
Intervention Description
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Intervention Type
Drug
Intervention Name(s)
Duramorph
Other Intervention Name(s)
Spinal Duramorph
Intervention Description
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Primary Outcome Measure Information:
Title
Pain Scores - Numerical Rating Scale, 0-10
Description
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative Opioid Consumption
Description
Opioid consumption measured in oral morphine equivalents
Time Frame
24 hours, 48 hours, 72 hours
Title
Patient Satisfaction
Description
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
Title
Extubation
Description
Time from arrival to ICU to extubation
Time Frame
Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
Title
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)
Title
Delirium Scores
Description
CAM-ICU scores at above time points
Time Frame
24, 48 and 72 hours
Title
Ionotropic Requirement
Description
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)
Title
Bowel Function
Description
Bowel Function
Time Frame
Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
Title
Ionotropic Requirement
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Praveen Prasanna, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Multimodal Analgesia in Cardiac Surgery (Pilot Study)

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