Heart DiseasesPhase 4NCT02734940
Multimodal Analgesia in Cardiac Surgery (Pilot Study)
A Phase 4 study testing Lidocaine, Unrestricted Fentanyl and Ketamine in people with Heart Diseases, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Lidocaine, Unrestricted Fentanyl and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2016to 1 Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective CABGs and/or Valve replacements, ≥ 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Heart Diseases
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called IV Lidocaine
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
Unrestricted FentanylDrug
Also called Unlimited intraoperative opiates
No changes to current practices, using unlimited narcotic medications intraoperatively.
KetamineDrug
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
PrecedexDrug
Also called IV Precedex
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
DuramorphDrug
Also called Spinal Duramorph
This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lidocaine; Drug: Ketamine; Drug: Precedex; Drug: Duramorph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores - Numerical Rating Scale, 0-10
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
Measured: 24 hours
Secondary outcomes (8)
Postoperative Opioid Consumption
Opioid consumption measured in oral morphine equivalents
Measured: 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)
Measured: 24 hours, 48 hours, 72 hours, 7 days, 30 days
Extubation
Time from arrival to ICU to extubation
Measured: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
ICU Length of Stay
Measured: 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
Measured: 24, 48 and 72 hours
Ionotropic Requirement
Total amount ionotropes required
Measured: 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
Measured: 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)
Measured: Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start11 Jul 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Why it stopped: Unable to find participants who met inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveen Prasanna, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734940
- Sponsor's protocol ID
- HM20004692
- Status last verified
- Jul 2018
- First submitted
- 9 Mar 2016
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesia in Cardiac Surgery (Pilot Study)
- ClinicalTrials.gov ID
- NCT02734940
- Acronym / sponsor ID
- HM20004692
- Conditions
- Heart Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to find participants who met inclusion/exclusion criteria
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unrestricted Fentanyl | Active comparator | Drug: Unrestricted FentanylWill 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 | Drug: Lidocaine, Drug: Ketamine, Drug: Precedex, Drug: DuramorphWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective CABGs and/or Valve replacements, ≥ 18 years old
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: IV LidocaineThis model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. | Drug | Lidocaine, Dexmedetomidine and Ketamine |
| Unrestricted FentanylAlso: Unlimited intraoperative opiatesNo changes to current practices, using unlimited narcotic medications intraoperatively. | Drug | Unrestricted Fentanyl |
| KetamineThis model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. | Drug | Lidocaine, Dexmedetomidine and Ketamine |
| PrecedexAlso: IV PrecedexThis model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. | Drug | Lidocaine, Dexmedetomidine and Ketamine |
| DuramorphAlso: Spinal DuramorphThis model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs. | Drug | Lidocaine, Dexmedetomidine and Ketamine |
Primary outcome
Pain Scores - Numerical Rating Scale, 0-10
Time frame: 24 hours
Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)
8 secondary outcomes
Postoperative Opioid Consumption
Time frame: 24 hours, 48 hours, 72 hours
Patient Satisfaction
Time frame: 24 hours, 48 hours, 72 hours, 7 days, 30 days
Extubation
Time frame: Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)
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)
Delirium Scores
Time frame: 24, 48 and 72 hours
Ionotropic Requirement
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)
Bowel Function
Time frame: Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)
Ionotropic Requirement
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Prasanna, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine, Unrestricted Fentanyl and Ketamine in people with Heart Diseases, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores - Numerical Rating Scale, 0-10 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.