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

NCT04197570 | Completed Phase 3 FDA Drug

• 1 other identifier: IRB19-024
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Opioid Free Anesthesia; Cardiac Surgery; Non-opioid Anesthesia; Dexmedetomidine; Hemodynamic; Opioid; Fentanyl; Cardiac Anesthesia; Cardiopulmonary Bypass; post sternotomy pain

Outcome Measures

Primary Outcomes (1)

• Mean arterial blood pressure-time integral

  The primary endpoint is the area under the baseline mean arterial pressure (MAP) over the first 10 minutes after induction, called the MAP-time integral.

  10 minutes

Secondary Outcomes (15)

• Blood pressure variability pre-cardiopulmonary bypass

  2 hours

• Heart rate variability pre-cardiopulmonary bypass

  2 hours

• Vasopressor usage intra- and post-operatively

  18 hours

• Arrhythmias or EKG changes

  14 days

• Delirium medications

  24 hours

Study Arms (2)

Opioid-based anesthetic

ACTIVE COMPARATOR

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

Drug: Opioid Anesthetics

Opioid-free anesthetic

EXPERIMENTAL

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

Drug: Non Opioid Analgesics

Interventions

Opioid Anesthetics DRUG

see arm/group description

Also known as: Opioid-based anesthetic

Opioid-based anesthetic

Non Opioid Analgesics DRUG

see arm/group description

Also known as: Opioid-free anesthetic

Opioid-free anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Interventions

Analgesics, Non-Narcotic

Intervention Hierarchy (Ancestors)

Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Sarah Bain

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators plan to enroll 158 subjects at Virginia Mason Medical Center that are undergoing open cardiac surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm. Subjects will be blinded to the assigned arm.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: February 4, 2020
• Primary Completion: March 14, 2020
• Study Completion: March 14, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)