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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197570
• Other study ID #: IRB19-024
• Status: Completed
• Phase: Phase 3
• Start date: February 4, 2020
• Est. completion date: March 14, 2020

Study information

• Verified date: July 2020
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 14, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Opioid Anesthetics
see arm/group description
• Non Opioid Analgesics
see arm/group description

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood pressure variability pre-cardiopulmonary bypass	highest and lowest blood pressure from induction to start of bypass	2 hours
Secondary	Heart rate variability pre-cardiopulmonary bypass	highest and lowest heart rate from induction to start of bypass	2 hours
Secondary	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	18 hours
Secondary	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.	14 days
Secondary	Delirium medications	Delirium medications administered 24 hours after ICU admission	24 hours
Secondary	Delirium	CAM-ICU scores at 12 hours and 24 hours after ICU admission	24 hours
Secondary	Postoperative pain scores	Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)	24 hours
Secondary	Opioid consumption	Total opioid utilization 24hours postoperatively (morphine equivalent dose)	24 hours
Secondary	Postoperative nausea/vomiting	Number of antiemetic doses administered	24 hours
Secondary	Time to extubation	Time from arrival in ICU to extubation	1-36 hours
Secondary	ICU length of stay	Time from arrival in ICU to time of transfer order out of ICU	1-5 days
Secondary	Hospital length of stay	Time begins day of surgery to day of discharge. Time in days	3-14 days
Secondary	Reintubation or readmission to ICU	After being extubated or being transferred out of ICU	0-14 days
Secondary	major adverse cardiovascular event or mortality	Major adverse cardiovascular event (eg., myocardial ischemia, stroke) or death	30 days
Secondary	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)	6 months