Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial

Completed · Phase 3

Conditions studied: Opioid Use, Heart; Surgery, Heart, Functional Disturbance as Result, Anesthesia

In brief

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.

Key facts

Study ID

NCT04197570

Run by

Benaroya Research Institute

People needed

9

Starts

2020-02-04

Expected to finish

2020-03-14

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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