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Completed

NCT Number: NCT04197570

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opioid Anesthetics

Drug

see arm/group description

Other names: Opioid-based anesthetic

Non Opioid Analgesics

Drug

see arm/group description

Other names: Opioid-free anesthetic

Primary outcomes

  1. 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.

Secondary outcomes

  1. Blood pressure variability pre-cardiopulmonary bypass

    Time frame: 2 hours

    highest and lowest blood pressure from induction to start of bypass

  2. Heart rate variability pre-cardiopulmonary bypass

    Time frame: 2 hours

    highest and lowest heart rate from induction to start of bypass

  3. 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

  4. 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.

  5. Delirium medications

    Time frame: 24 hours

    Delirium medications administered 24 hours after ICU admission

  6. Delirium

    Time frame: 24 hours

    CAM-ICU scores at 12 hours and 24 hours after ICU admission

  7. 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)

  8. Opioid consumption

    Time frame: 24 hours

    Total opioid utilization 24hours postoperatively (morphine equivalent dose)

  9. Postoperative nausea/vomiting

    Time frame: 24 hours

    Number of antiemetic doses administered

  10. Time to extubation

    Time frame: 1-36 hours

    Time from arrival in ICU to extubation

  11. ICU length of stay

    Time frame: 1-5 days

    Time from arrival in ICU to time of transfer order out of ICU

  12. Hospital length of stay

    Time frame: 3-14 days

    Time begins day of surgery to day of discharge. Time in days

  13. Reintubation or readmission to ICU

    Time frame: 0-14 days

    After being extubated or being transferred out of ICU

  14. major adverse cardiovascular event or mortality

    Time frame: 30 days

    Major adverse cardiovascular event (eg., myocardial ischemia, stroke) or death

  15. 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)

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Collaborators

  • Virginia Mason Hospital/Medical Center

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2019
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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