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

• Status: Completed
• Trial end date: 2020-03-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benaroya Research Institute
• Collaborator: Virginia Mason Hospital/Medical Center
• Treatments: Analgesics; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthetics; Dexmedetomidine; Fentanyl

Criteria

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.