Clinical trial NCT04197570: Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial
Official title: Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
First posted: 2019-12-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Mean arterial blood pressure-time integral
timeFrame: 10 minutes
Secondary outcomes:
measure: Blood pressure variability pre-cardiopulmonary bypass
timeFrame: 2 hours
measure: Heart rate variability pre-cardiopulmonary bypass
timeFrame: 2 hours
measure: Vasopressor usage intra- and post-operatively
timeFrame: 18 hours
measure: Arrhythmias or EKG changes
timeFrame: 14 days
measure: Delirium medications
timeFrame: 24 hours
measure: Delirium
timeFrame: 24 hours
measure: Postoperative pain scores
timeFrame: 24 hours
measure: Opioid consumption
timeFrame: 24 hours
measure: Postoperative nausea/vomiting
timeFrame: 24 hours
measure: Time to extubation
timeFrame: 1-36 hours
measure: ICU length of stay
timeFrame: 1-5 days
measure: Hospital length of stay
timeFrame: 3-14 days
measure: Reintubation or readmission to ICU
timeFrame: 0-14 days
measure: major adverse cardiovascular event or mortality
timeFrame: 30 days
measure: Postoperative pain questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Sarah Bain
role: PRINCIPAL_INVESTIGATOR
References: