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Multimodal Analgesia in Cardiac Surgery (Pilot Study)

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ClinicalTrials.gov Identifier: NCT02734940
Recruitment Status : Terminated (Unable to find participants who met inclusion/exclusion criteria)
First Posted : April 12, 2016
Results First Posted : February 19, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Heart Diseases
Interventions Drug: Lidocaine
Drug: Unrestricted Fentanyl
Drug: Ketamine
Drug: Precedex
Drug: Duramorph
Enrollment 3
Recruitment Details The study was terminated because of lack of enrollment. No data was ever collected.
Pre-assignment Details  
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine Total
Hide Arm/Group 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.

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

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. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
1.Primary Outcome
Title Pain Scores - Numerical Rating Scale, 0-10
Hide Description Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Postoperative Opioid Consumption
Hide Description Opioid consumption measured in oral morphine equivalents
Time Frame 24 hours, 48 hours, 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Patient Satisfaction
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Extubation
Hide Description Time from arrival to ICU to extubation
Time Frame Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title ICU Length of Stay
Hide Description [Not Specified]
Time Frame Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Delirium Scores
Hide Description CAM-ICU scores at above time points
Time Frame 24, 48 and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Ionotropic Requirement
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Bowel Function
Hide Description Bowel Function
Time Frame Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Ionotropic Requirement
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated because of lack of enrollment. No data was collected.
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame No data was collected because no participants started the study.
Adverse Event Reporting Description The study was terminated because of lack of enrollment.
 
Arm/Group Title Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Hide Arm/Group 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.

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

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.
All-Cause Mortality
Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Unrestricted Fentanyl Lidocaine, Dexmedetomidine and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jessica Potter
Organization: Virginia Commonwealth University
Phone: (804) 828-2755
EMail: jessica.potter@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02734940    
Other Study ID Numbers: HM20004692
First Submitted: March 9, 2016
First Posted: April 12, 2016
Results First Submitted: January 22, 2018
Results First Posted: February 19, 2018
Last Update Posted: August 7, 2018