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Anesthesia Comparison for Coronary Artery Disease Surgery (ETOPRO Trial)

Phase 4

Recruiting

Led By Joseph Hinchey, MD

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled for elective open coronary arteries bypass graft CABG surgery

Be older than 18 years old

Must not have

Emergency CABG surgery, STAT cases, and add-on cases

Patients with a known current adrenocortical insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effects of two drugs used to induce anesthesia in CABG surgery patients, to see which has better outcomes for hemodynamic support, ventilation, ICU & hospital stays, mortality, & readmission rates.

Who is the study for?

This trial is for patients who can communicate in English or Spanish, are scheduled for elective open coronary artery bypass graft (CABG) surgery, and have an ASA score of I-IV. It excludes those with emergency CABG needs, known allergies to etomidate or propofol, seizure disorders, current participation in competing studies, shock conditions, or chronic steroid use within the last 6 months.

What is being tested?

The study compares etomidate and propofol as anesthesia induction agents during CABG surgery. Participants will be randomly assigned to receive one of these drugs. Researchers will monitor hemodynamic support needs, stability during and after surgery, ventilation time, ICU stay duration, hospital stay length plus mortality and readmission rates over six months.

What are the potential side effects?

Potential side effects from etomidate may include adrenal insufficiency and muscle movements while propofol can cause low blood pressure or allergic reactions. Both drugs could affect heart rate and breathing requiring close monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for an elective open heart bypass surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am undergoing or have undergone emergency coronary artery bypass surgery.

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I have a condition where my adrenal glands do not produce enough hormones.

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I am currently experiencing a severe drop in blood pressure.

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I have a known seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]

Secondary study objectives

Hospital Readmissions

Hospital length of stay

ICU length of stay

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EtomidateExperimental Treatment1 Intervention

Etomidate as the principal hypnotic agent in a single bolus dose of 0.2-0.3 mg/kg along with 250mcg of fentanyl, 50mg ketamine, 0.7 mg/kg rocuronium, and 5ml of 2% lidocaine.

Group II: PropofolActive Control1 Intervention

Propofol as the principal hypnotic agent in a single bolus dose of 50mg of propofol along with 250 mcg of fentanyl, 50mg ketamine, 0.7 mg/kg rocuronium, and 5ml of 2% lidocaine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etomidate

2023

Completed Phase 4

~6980

0 / 5Eligibility criteria met