Virginia Mason Medical Center
Seattle, Washington, 98101, United States
NCT Number: NCT04197570
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Seattle, Washington, 98101, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
see arm/group description
Other names: Opioid-based anesthetic
see arm/group description
Other names: Opioid-free anesthetic
Time frame: 10 minutes
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: 2 hours
highest and lowest blood pressure from induction to start of bypass
Time frame: 2 hours
highest and lowest heart rate from induction to start of bypass
Time frame: 18 hours
Number of vasopressors and doses from induction to start of cardiopulmonary bypass, leaving operating room and 12 hours postop
Time frame: 14 days
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: 24 hours
Delirium medications administered 24 hours after ICU admission
Time frame: 24 hours
CAM-ICU scores at 12 hours and 24 hours after ICU admission
Time frame: 24 hours
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Time frame: 24 hours
Total opioid utilization 24hours postoperatively (morphine equivalent dose)
Time frame: 24 hours
Number of antiemetic doses administered
Time frame: 1-36 hours
Time from arrival in ICU to extubation
Time frame: 1-5 days
Time from arrival in ICU to time of transfer order out of ICU
Time frame: 3-14 days
Time begins day of surgery to day of discharge. Time in days
Time frame: 0-14 days
After being extubated or being transferred out of ICU
Time frame: 30 days
Major adverse cardiovascular event (eg., myocardial ischemia, stroke) or death
Time frame: 6 months
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)
Benaroya Research Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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