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

NCT ID: NCT04197570

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2020-03-14

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Opioid-based anesthetic

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

Group Type: ACTIVE_COMPARATOR

Opioid Anesthetics

Intervention Type: DRUG

see arm/group description

Opioid-free anesthetic

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

Group Type: EXPERIMENTAL

Non Opioid Analgesics

Intervention Type: DRUG

see arm/group description

Interventions

Opioid Anesthetics

see arm/group description

Intervention Type: DRUG

Non Opioid Analgesics

see arm/group description

Intervention Type: DRUG

Other Intervention Names

Opioid-based anesthetic; Opioid-free anesthetic

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Bain

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

IRB19-024

Identifier Type: -

Identifier Source: org_study_id