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| Name | Class |
|---|---|
| Virginia Mason Hospital/Medical Center | OTHER |
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This study will compare an opioid free anesthetic, using dexmedetomidine, to a traditional opioid based anesthetic, using fentanyl, for patients undergoing cardiac surgery with regards to hemodynamic stability in the first 10 minutes after induction.
This is a single center, blinded, prospective, randomized controlled trial. A total of 158 subjects (79 subjects in each arm) are planned. The control group will receive a traditional cardiac anesthetic using opioids, for which induction will include fentanyl and propofol. The experimental arm will receive an opioid free anesthetic with an induction bolus of dexmedetomidine and propofol. The investigators hypothesize that using the opioid free technique will be more hemodynamically stable within the first 10 minutes of induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-based anesthetic | Active Comparator | Premedication -midazolam 2mg IV x 1 as need for anxiety, at the discretion of the anesthesiologist Induction
Maintenance
During chest closure:
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|
| Opioid-free anesthetic | Experimental | Premedication -midazolam 2mg IVx1 as needed for anxiety, at the discretion of the anesthesiologist Induction
Maintenance
During chest closure:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Anesthetics | Drug | see arm/group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial blood pressure-time integral | The primary endpoint is the area under the baseline mean arterial pressure (MAP) over the first 10 minutes after induction, called the MAP-time integral. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure variability pre-cardiopulmonary bypass | highest and lowest blood pressure from induction to start of bypass | 2 hours |
| Heart rate variability pre-cardiopulmonary bypass | highest and lowest heart rate from induction to start of bypass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Bain | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| ID | Term |
|---|---|
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
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The investigators plan to enroll 158 subjects at Virginia Mason Medical Center that are undergoing open cardiac surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm. Subjects will be blinded to the assigned arm.
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| Non Opioid Analgesics | Drug | see arm/group description |
|
|
| 2 hours |
| Vasopressor usage intra- and post-operatively | Number of vasopressors and doses from induction to start of cardiopulmonary bypass, leaving operating room and 12 hours postop | 18 hours |
| Arrhythmias or EKG changes | Intraoperative EKG changes or evidence of echocardiographic ischemia prior to heparin. Antiarrhythmic medications given intraoperative or in first 24 hours postop. New permanent pacemaker placed during hospital admission. | 14 days |
| Delirium medications | Delirium medications administered 24 hours after ICU admission | 24 hours |
| Delirium | CAM-ICU scores at 12 hours and 24 hours after ICU admission | 24 hours |
| Postoperative pain scores | Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain) | 24 hours |
| Opioid consumption | Total opioid utilization 24hours postoperatively (morphine equivalent dose) | 24 hours |
| Postoperative nausea/vomiting | Number of antiemetic doses administered | 24 hours |
| Time to extubation | Time from arrival in ICU to extubation | 1-36 hours |
| ICU length of stay | Time from arrival in ICU to time of transfer order out of ICU | 1-5 days |
| Hospital length of stay | Time begins day of surgery to day of discharge. Time in days | 3-14 days |
| Reintubation or readmission to ICU | After being extubated or being transferred out of ICU | 0-14 days |
| major adverse cardiovascular event or mortality | Major adverse cardiovascular event (eg., myocardial ischemia, stroke) or death | 30 days |
| Postoperative pain questionnaire | 30 day, 3 month and 6 month pain questionnaire as well as post-sternotomy opioid use (as determined by reviewing Washington PMP data). Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain) | 6 months |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |