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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
9
see arm/group description
see arm/group description
Virginia Mason Medical Center
Seattle, Washington, United States
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.
Time frame: 10 minutes
Blood pressure variability pre-cardiopulmonary bypass
highest and lowest blood pressure from induction to start of bypass
Time frame: 2 hours
Heart rate variability pre-cardiopulmonary bypass
highest and lowest heart rate from induction to start of bypass
Time frame: 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
Time frame: 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.
Time frame: 14 days
Delirium medications
Delirium medications administered 24 hours after ICU admission
Time frame: 24 hours
Delirium
CAM-ICU scores at 12 hours and 24 hours after ICU admission
Time frame: 24 hours
Postoperative pain scores
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Time frame: 24 hours
Opioid consumption
Total opioid utilization 24hours postoperatively (morphine equivalent dose)
Time frame: 24 hours
Postoperative nausea/vomiting
Number of antiemetic doses administered
Time frame: 24 hours
Time to extubation
Time from arrival in ICU to extubation
Time frame: 1-36 hours
ICU length of stay
Time from arrival in ICU to time of transfer order out of ICU
Time frame: 1-5 days
Hospital length of stay
Time begins day of surgery to day of discharge. Time in days
Time frame: 3-14 days
Reintubation or readmission to ICU
After being extubated or being transferred out of ICU
Time frame: 0-14 days
major adverse cardiovascular event or mortality
Major adverse cardiovascular event (eg., myocardial ischemia, stroke) or death
Time frame: 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)
Time frame: 6 months