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

Benaroya Research Institute

Status and phase: Completed; Phase 3

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

Treatments: Drug: Opioid Anesthetics; Drug: Non Opioid Analgesics

Study type: Interventional

Funder types: Other

Identifiers

NCT04197570

IRB19-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Opioid-based anesthetic

Active Comparator group

Description:

Premedication -midazolam 2mg IV x 1 as need for anxiety, at the discretion of the anesthesiologist Induction * Fentanyl 2-4 mcg/kg IV bolus * Propofol 1-3 mg/kg IV * Paralytic and vasoactive medications at the discretion of the anesthesiologist Maintenance * Fentanyl 1-2 mcg/kg IV bolus immediately prior to sternotomy \& aortic cannulation * Fentanyl 1-2mcg/kg IV bolus immediately following removal of bypass cannula * Dexmedetomidine 0.4 mcg/kg/hr IV infusion * Isoflurane titrated at the discretion of the anesthesiologist * Vasoactive medications at the discretion of the anesthesiologist for hemodynamic management During chest closure: * start Propofol 25-75mcg/kg/min IV infusion * continue dexmedetomidine 0.4mcg/kg/hr IV infusion * titrate off isoflurane * Acetaminophen 1000mg IV

Treatment:

Drug: Opioid Anesthetics

Opioid-free anesthetic

Experimental group

Description:

Premedication -midazolam 2mg IVx1 as needed for anxiety, at the discretion of the anesthesiologist Induction * Dexmedetomidine 1mcg/kg IV * Propofol 1-3mg/kg IV * Paralytic and vasoactive medications at the discretion of the anesthesiologist Maintenance * Dexmedetomidine 0.8-1.0 mcg/kg/hr IV infusion * Isoflurane titrated at the discretion of the anesthesiologist * May add propofol infusion if clinically indicated * Vasoactive medications at the discretion of the anesthesiologist for hemodynamic management During chest closure: * start Propofol 25-75mcg/kg/min IV infusion * continue dexmedetomidine 0.4 - 1.0 mcg/kg/hr IV infusion * titrate off isoflurane * Acetaminophen 1000mg IV

Treatment:

Drug: Non Opioid Analgesics