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Unable to find participants who met inclusion/exclusion criteria
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Opioid Consumption | Opioid consumption measured in oral morphine equivalents | 24 hours, 48 hours, 72 hours |
| Patient Satisfaction | Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Praveen Prasanna, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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The study was terminated because of lack of enrollment. No data was ever collected.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated because of lack of enrollment. No data was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores - Numerical Rating Scale, 0-10 | Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded) | The study was terminated because of lack of enrollment. No data was collected. | Posted | 24 hours |
|
No data was collected because no participants started the study.
The study was terminated because of lack of enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Potter | Virginia Commonwealth University | (804) 828-2755 | jessica.potter@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2016 | Jan 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D007649 | Ketamine |
| D020927 | Dexmedetomidine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| 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. |
|
|
| 24 hours, 48 hours, 72 hours, 7 days, 30 days |
| Extubation | Time from arrival to ICU to 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 | CAM-ICU scores at above time points | 24, 48 and 72 hours |
| Ionotropic Requirement | Total amount ionotropes required | Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days) |
| Bowel Function | Bowel Function | Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days) |
| Ionotropic Requirement | Total duration of ionotropic requirement (hours) | Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| OG001 | 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. |
|
| Secondary | Postoperative Opioid Consumption | Opioid consumption measured in oral morphine equivalents | The study was terminated because of lack of enrollment. No data was collected. | Posted | 24 hours, 48 hours, 72 hours |
|
|
| 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) | The study was terminated because of lack of enrollment. No data was collected. | Posted | 24 hours, 48 hours, 72 hours, 7 days, 30 days |
|
|
| Secondary | Extubation | Time from arrival to ICU to extubation | The study was terminated because of lack of enrollment. No data was collected. | Posted | Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours) |
|
|
| Secondary | ICU Length of Stay | The study was terminated because of lack of enrollment. No data was collected. | Posted | Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days) |
|
|
| Secondary | Delirium Scores | CAM-ICU scores at above time points | The study was terminated because of lack of enrollment. No data was collected. | Posted | 24, 48 and 72 hours |
|
|
| Secondary | Ionotropic Requirement | Total amount ionotropes required | The study was terminated because of lack of enrollment. No data was collected. | Posted | Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days) |
|
|
| Secondary | Bowel Function | Bowel Function | The study was terminated because of lack of enrollment. No data was collected. | Posted | Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days) |
|
|
| Secondary | Ionotropic Requirement | Total duration of ionotropic requirement (hours) | The study was terminated because of lack of enrollment. No data was collected. | Posted | Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |