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

July 24, 2020 updated by: Benaroya Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 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
Drug: Opioid Anesthetics
see arm/group description
Other Names:
  • Opioid-based anesthetic
EXPERIMENTAL: 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
Drug: Non Opioid Analgesics
see arm/group description
Other Names:
  • Opioid-free anesthetic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure variability pre-cardiopulmonary bypass
Time Frame: 2 hours
highest and lowest blood pressure from induction to start of bypass
2 hours
Heart rate variability pre-cardiopulmonary bypass
Time Frame: 2 hours
highest and lowest heart rate from induction to start of bypass
2 hours
Vasopressor usage intra- and post-operatively
Time Frame: 18 hours
Number of vasopressors and doses from induction to start of cardiopulmonary bypass, leaving operating room and 12 hours postop
18 hours
Arrhythmias or EKG changes
Time Frame: 14 days
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.
14 days
Delirium medications
Time Frame: 24 hours
Delirium medications administered 24 hours after ICU admission
24 hours
Delirium
Time Frame: 24 hours
CAM-ICU scores at 12 hours and 24 hours after ICU admission
24 hours
Postoperative pain scores
Time Frame: 24 hours
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
24 hours
Opioid consumption
Time Frame: 24 hours
Total opioid utilization 24hours postoperatively (morphine equivalent dose)
24 hours
Postoperative nausea/vomiting
Time Frame: 24 hours
Number of antiemetic doses administered
24 hours
Time to extubation
Time Frame: 1-36 hours
Time from arrival in ICU to extubation
1-36 hours
ICU length of stay
Time Frame: 1-5 days
Time from arrival in ICU to time of transfer order out of ICU
1-5 days
Hospital length of stay
Time Frame: 3-14 days
Time begins day of surgery to day of discharge. Time in days
3-14 days
Reintubation or readmission to ICU
Time Frame: 0-14 days
After being extubated or being transferred out of ICU
0-14 days
major adverse cardiovascular event or mortality
Time Frame: 30 days
Major adverse cardiovascular event (eg., myocardial ischemia, stroke) or death
30 days
Postoperative pain questionnaire
Time Frame: 6 months
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Benaroya Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Virginia Mason Hospital/Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah Bain, Virginia Mason Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB19-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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