Opioid UsePhase 3NCT04197570

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

A Phase 3 study testing Opioid Anesthetics and Non Opioid Analgesics in people with Opioid Use and Heart; Surgery, Heart, Functional Disturbance as Result, run by Benaroya Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Use, Heart; Surgery, Heart, Functional Disturbance as Result, Anesthesia
What is being tested?: Opioid Anesthetics and Non Opioid Analgesics
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2020to 14 Mar 2020
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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Pregnancy or lactating.
Inability to comply with the requirements of the study, per investigator judgment.
Patients determined to need an awake intubation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Mason Medical Center
Seattle, Washington, 98101

Other trials in United States

About this study

Read the 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
Being tested: Opioid Anesthetics, Non Opioid Analgesics
Keywords: Opioid Free Anesthesia, Cardiac Surgery, Non-opioid Anesthesia, Dexmedetomidine, Hemodynamic, Opioid, Fentanyl, Cardiac Anesthesia, Cardiopulmonary Bypass, post sternotomy pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opioid AnestheticsDrug
Also called Opioid-based anesthetic
see arm/group description
Non Opioid AnalgesicsDrug
Also called Opioid-free anesthetic
see arm/group description

Study groups in NCT04197570
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Non Opioid Analgesics

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10 minutes

Secondary outcomes (15)

Blood pressure variability pre-cardiopulmonary bypass
highest and lowest blood pressure from induction to start of bypass
Measured: 2 hours
Heart rate variability pre-cardiopulmonary bypass
highest and lowest heart rate from induction to start of bypass
Measured: 2 hours
Vasopressor usage intra- and post-operatively
Number of vasopressors and doses from induction to start of cardiopulmonary bypass, leaving operating room and 12 hours postop
Measured: 18 hours
Arrhythmias or EKG changes
Intraoperative EKG changes or evidence of echocardiographic ischemia prior to heparin. Antiarrhythmic medications given intraoperative or in first 24 hours postop. New permanent pacemaker placed during hospital admission.
Measured: 14 days
Delirium medications
Delirium medications administered 24 hours after ICU admission
Measured: 24 hours
Delirium
CAM-ICU scores at 12 hours and 24 hours after ICU admission
Measured: 24 hours
Postoperative pain scores
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Measured: 24 hours
Opioid consumption
Total opioid utilization 24hours postoperatively (morphine equivalent dose)
Measured: 24 hours
Postoperative nausea/vomiting
Number of antiemetic doses administered
Measured: 24 hours
Time to extubation
Time from arrival in ICU to extubation
Measured: 1-36 hours
ICU length of stay
Time from arrival in ICU to time of transfer order out of ICU
Measured: 1-5 days
Hospital length of stay
Time begins day of surgery to day of discharge. Time in days
Measured: 3-14 days
Reintubation or readmission to ICU
After being extubated or being transferred out of ICU
Measured: 0-14 days
major adverse cardiovascular event or mortality
Major adverse cardiovascular event (eg., myocardial ischemia, stroke) or death
Measured: 30 days
Postoperative pain questionnaire
30 day, 3 month and 6 month pain questionnaire as well as post-sternotomy opioid use (as determined by reviewing Washington PMP data). Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 202014 Mar 2020

First posted13 Dec 2019
Study start4 Feb 2020
Primary completion14 Mar 2020
Study completion14 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Opioid UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Participant
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04197570
Sponsor's protocol ID: IRB19-024
Status last verified: Jul 2020
First submitted: 11 Dec 2019
Last updated: 28 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Use trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04197570
Acronym / sponsor ID: IRB19-024
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Benaroya Research InstituteUniversity, hospital or other
Collaborators: Virginia Mason Hospital/Medical Center
Study start: 4 Feb 2020 (actual)
Primary completion: 14 Mar 2020 (actual)
Study completion: 14 Mar 2020 (actual)
First posted: 13 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
Opioid-based anesthetic	Active comparator	Drug: Opioid AnestheticsPremedication -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
Opioid-free anesthetic	Experimental	Drug: Non Opioid AnalgesicsPremedication -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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Opioid AnestheticsAlso: Opioid-based anestheticsee arm/group description	Drug	Opioid-based anesthetic
Non Opioid AnalgesicsAlso: Opioid-free anestheticsee arm/group description	Drug	Opioid-free anesthetic

Primary outcome

Mean arterial blood pressure-time integral
Time frame: 10 minutes
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.

15 secondary outcomes

Blood pressure variability pre-cardiopulmonary bypass
Time frame: 2 hours
Heart rate variability pre-cardiopulmonary bypass
Time frame: 2 hours
Vasopressor usage intra- and post-operatively
Time frame: 18 hours
Arrhythmias or EKG changes
Time frame: 14 days
Delirium medications
Time frame: 24 hours
Delirium
Time frame: 24 hours
Postoperative pain scores
Time frame: 24 hours
Opioid consumption
Time frame: 24 hours
Postoperative nausea/vomiting
Time frame: 24 hours
Time to extubation
Time frame: 1-36 hours
ICU length of stay
Time frame: 1-5 days
Hospital length of stay
Time frame: 3-14 days
Reintubation or readmission to ICU
Time frame: 0-14 days
major adverse cardiovascular event or mortality
Time frame: 30 days
Postoperative pain questionnaire
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Individual participant dataSharing planned: No

Related trials for Opioid Use

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah Bain principal investigator

Virginia Mason Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean arterial blood pressure-time integral (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04197570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.