Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial (NCT04197570) | Clinical Trial Compass
CompletedPhase 3
Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial
United States9 participantsStarted 2020-02-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female ≥ 18 years of age at the time of consent.
* Undergoing non-emergent open cardiac procedures requiring cardiopulmonary bypass support, including: CABG, aortic aneurysm repair, valve repair/replacement, or CABG in combination with valve repair/replacement.
* Ability and willingness to provide written informed consent.
Exclusion Criteria:
* Chronic opioid use defined as preoperative MED \>100 daily.
* Hypersensitivity or contraindication to any of the study medications.
* Pre-existing Alzheimer's/vascular dementia.
* Pre-existing psychiatric disorder precluding ability to provide informed consent or use a visual analogue scale for pain.
* Childs-Pugh Class C liver failure or acute liver failure.
* Emergent open heart surgery, including type A aortic dissections, trauma, or conversion (bail out) from another procedure such as cardiac catheterization, ablation, transcatheter aortic valve replacement or any other general surgical procedure.
* Pregnancy or lactating.
* Inability to comply with the requirements of the study, per investigator judgment.
* Patients determined to need an awake intubation.