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

Last updated: July 24, 2020
Sponsor: Benaroya Research Institute
Overall Status: Completed

Phase

3

Condition

Drug Use

Anesthesia

Treatment

N/A

Clinical Study ID

NCT04197570
IRB19-024
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female ≥ 18 years of age at the time of consent.

  • Undergoing non-emergent open cardiac procedures requiring cardiopulmonary bypasssupport, including: CABG, aortic aneurysm repair, valve repair/replacement, or CABG incombination with valve repair/replacement.

  • Ability and willingness to provide written informed consent.

Exclusion

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 oruse 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, orconversion (bail out) from another procedure such as cardiac catheterization,ablation, transcatheter aortic valve replacement or any other general surgicalprocedure.

  • Pregnancy or lactating.

  • Inability to comply with the requirements of the study, per investigator judgment.

  • Patients determined to need an awake intubation.

Study Design

Total Participants: 9
Study Start date:
February 04, 2020
Estimated Completion Date:
March 14, 2020

Study Description

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.

Connect with a study center

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

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