Trial Outcomes & Findings for Multimodal Analgesia in Cardiac Surgery (Pilot Study) (NCT NCT02734940)
NCT ID: NCT02734940
Last Updated: 2018-08-07
Results Overview
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
TERMINATED
PHASE4
3 participants
24 hours
2018-08-07
Participant Flow
The study was terminated because of lack of enrollment. No data was ever collected.
Participant milestones
| Measure |
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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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.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multimodal Analgesia in Cardiac Surgery (Pilot Study)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 24 hoursPopulation: The study was terminated because of lack of enrollment. No data was collected.
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 72 hoursPopulation: The study was terminated because of lack of enrollment. No data was collected.
Opioid consumption measured in oral morphine equivalents
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 72 hours, 7 days, 30 daysPopulation: The study was terminated because of lack of enrollment. No data was collected.
Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)Population: The study was terminated because of lack of enrollment. No data was collected.
Time from arrival to ICU to extubation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)Population: The study was terminated because of lack of enrollment. No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24, 48 and 72 hoursPopulation: The study was terminated because of lack of enrollment. No data was collected.
CAM-ICU scores at above time points
Outcome measures
Outcome data not reported
SECONDARY outcome
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)Population: The study was terminated because of lack of enrollment. No data was collected.
Total amount ionotropes required
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)Population: The study was terminated because of lack of enrollment. No data was collected.
Bowel Function
Outcome measures
Outcome data not reported
SECONDARY outcome
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)Population: The study was terminated because of lack of enrollment. No data was collected.
Total duration of ionotropic requirement (hours)
Outcome measures
Outcome data not reported
Adverse Events
Unrestricted Fentanyl
Lidocaine, Dexmedetomidine and Ketamine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place