Anesthesia Comparison for Coronary Artery Disease Surgery

(ETOPRO Trial)

Overseen By Aseel Walker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hartford Hospital

Must not be taking: Chronic steroids

Disqualifiers: Adrenocortical insufficiency, Shock, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative period

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two anesthesia drugs, etomidate and propofol, perform for individuals undergoing coronary artery bypass surgery. The goal is to determine which drug better maintains stable blood pressure and reduces the need for additional heart support during and after surgery. Researchers will also assess the duration of time patients remain on a breathing machine, their ICU stay, and their overall hospital stay. Individuals scheduled for planned coronary artery bypass surgery who speak English or Spanish might be suitable candidates. The results could guide doctors in selecting the best anesthesia for future heart surgeries. As a Phase 4 trial, this research aims to understand how these FDA-approved drugs can benefit more patients undergoing heart surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using chronic steroids or have a known allergy to etomidate or propofol, you may not be eligible to participate.

What is the safety track record for etomidate and propofol?

Research has shown that both etomidate and propofol are generally well-tolerated for initiating anesthesia. Etomidate is often selected for heart surgery due to its gentle effects on the heart and blood vessels. A review of studies found that etomidate is commonly used and considered safe for heart surgery patients.

Propofol is also widely used and has been studied for its effects during surgery. Research indicates that while propofol is effective, etomidate might be preferable for certain heart conditions. However, propofol is known for providing good sedation, and patients typically wake up quickly after surgery.

In summary, both treatments have been used extensively in heart surgeries and are considered safe. Each has its strengths, so the choice often depends on the specific needs of the patient. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the effectiveness and safety of two anesthetic agents, Etomidate and Propofol, used during coronary artery disease surgery. Etomidate is known for its minimal cardiovascular effects, which makes it potentially beneficial for heart patients. On the other hand, Propofol is commonly praised for its rapid onset and recovery times. By comparing these two, the trial aims to determine which anesthetic provides better outcomes, especially in terms of hemodynamic stability and recovery profile, for patients undergoing heart surgery.

What evidence suggests that this trial's treatments could be effective for coronary artery disease surgery?

This trial will compare etomidate and propofol as anesthesia options for coronary artery disease surgery. Research has shown that etomidate might be slightly better for heart health during surgery. For individuals with coronary heart disease (CHD), etomidate is associated with fewer heart issues and more stable blood pressure during surgery. Conversely, propofol is known for helping patients wake up faster after surgery. These benefits make both etomidate and propofol viable options for anesthesia in heart surgery, each with distinct strengths. Participants in this trial will receive either etomidate or propofol as part of their anesthesia regimen. ^{1 2 3 4 5}

Who Is on the Research Team?

Joseph Hinchey, MD

Principal Investigator

Hartford Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for an elective open heart bypass surgery.

You have a physical status score of I-IV according to the American Society of Anesthesiology.

I can speak and read both English and Spanish.

Exclusion Criteria

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

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

I have a known seizure disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either etomidate or propofol as the principal hypnotic agent during CABG surgery

Intraoperative period

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for hemodynamic stability and vasopressor requirements

First 24 hours post anesthesia

ICU Stay

Participants' length of stay in the ICU is monitored

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission and mortality rates

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Etomidate
• Propofol

Trial Overview 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.

How Is the Trial Designed?

Group I: Etomidate Experimental Treatment 1 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: Propofol Active Control 1 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.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Published Research Related to This Trial

In a study of 100 patients undergoing elective surgery, etomidate demonstrated better hemodynamic stability compared to propofol, with minimal changes in mean arterial pressure and heart rate during induction.

While propofol caused more pain upon injection, etomidate was associated with higher instances of myoclonus, suggesting that etomidate may be a safer choice for hemodynamically unstable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study between propofol and etomidate in patients under general anesthesia. Aggarwal, S., Goyal, VK., Chaturvedi, SK., et al.[2022]

In a randomized controlled trial involving 164 patients with coronary artery disease undergoing noncardiac surgery, sevoflurane-remifentanil anesthesia did not show any significant advantage over propofol-remifentanil in preventing in-hospital cardiovascular events.

While both anesthesia types resulted in similar in-hospital morbidity and mortality rates, sevoflurane was associated with a higher frequency of postoperative nausea and vomiting compared to propofol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sevoflurane-Remifentanil Versus Propofol-Remifentanil Anesthesia During Noncardiac Surgery for Patients with Coronary Artery Disease - A Prospective Study Between 2016 and 2017 at a Single Center. Dai, Z., Lin, M., Li, Y., et al.[2022]

In a study of 8,978 patients undergoing cardiac surgery, etomidate was not linked to a higher risk of postoperative atrial arrhythmia compared to other induction agents, suggesting it is a safe option for anesthesia in these patients.

Etomidate did not lead to longer stays in the intensive care unit or hospital, although it was associated with a higher likelihood of requiring packed red blood cells during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etomidate and the Risk of Complications After Cardiac Surgery: A Retrospective Cohort Analysis. Komatsu, R., Makarova, N., You, J., et al.[2017]

In a study involving 60 patients with coronary artery disease and left ventricular dysfunction, all four anesthetic agents (etomidate, midazolam, thiopentone, and propofol) caused significant decreases in heart rate, mean arterial pressure, cardiac index, and stroke volume index after induction, indicating a notable impact on hemodynamics during anesthesia induction.

Midazolam was found to be the most effective in preventing intubation stress, showing no significant changes in heart rate and mean arterial pressure after intubation, while etomidate was the least effective, with significant increases in these parameters, highlighting the importance of agent selection in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of anesthetic induction agents in patients with coronary artery disease and left ventricular dysfunction. Singh, R., Choudhury, M., Kapoor, PM., et al.[2022]

In a study of 1,462 cardiac surgery patients, etomidate did not significantly increase the risk of postoperative sepsis compared to propofol, with rates of 11.5% for etomidate versus 8.2% for propofol (p = 0.052).

However, patients receiving etomidate were more likely to develop hospital-acquired pneumonia (18.6% vs. 14.0% for propofol, p = 0.031), indicating a potential safety concern with etomidate use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious Complications after Etomidate vs. Propofol for Induction of General Anesthesia in Cardiac Surgery-Results of a Retrospective, before-after Study. Weiss, B., Schiefenhövel, F., Grunow, JJ., et al.[2021]

In a study of 84 patients with left ventricular dysfunction undergoing CABG surgery, etomidate was found to provide better hemodynamic stability compared to the ketamine-propofol combination (ketofol) during anesthesia induction.

The ketofol group experienced greater decreases in blood pressure and heart rate, leading to a higher need for ephedrine to manage these changes, indicating that etomidate is a safer option for patients with compromised heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing hemodynamic responses to ketamine-propofol combination (ketofol) versus etomidate during anesthesia induction in patients with left ventricular dysfunction undergoing coronary artery bypass graft surgery. Baradari, AG., Alipour, A., Habibi, MR., et al.[2020]

In a study of 150 patients with coronary artery disease and low ejection fraction undergoing CABG surgery, diazepam was found to provide better hemodynamic stability compared to propofol and etomidate during anesthesia induction.

Patients receiving diazepam experienced less decrease in blood pressure and heart rate after induction, making it a safer option for those with impaired ventricular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Hemodynamic Responses to Diazepam, Propofol and Etomidate During Anesthesia Induction in Patients with Left Ventricular Dysfunction Undergoing Coronary Artery Bypass Graft Surgery: a Double-blind, Randomized Clinical Trial. Soleimani, A., Heidari, N., Habibi, MR., et al.[2019]

In a study of 100 patients undergoing elective surgery, etomidate demonstrated better hemodynamic stability compared to propofol, with minimal changes in mean arterial pressure and heart rate during induction.

While propofol was associated with more pain on injection, etomidate resulted in higher instances of myoclonus, suggesting that etomidate may be a safer choice for hemodynamically unstable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparative study between propofol and etomidate in patients under general anesthesia]. Aggarwal, S., Goyal, VK., Chaturvedi, SK., et al.[2016]

In a study of 128 patients undergoing endoscopic procedures, etomidate was associated with significantly fewer cases of oxygen desaturation (6.25% vs 31.25%) and respiratory depression (7.81% vs 32.81%) compared to propofol, indicating better respiratory safety.

While etomidate showed improved respiratory outcomes and higher physician satisfaction, it was linked to a higher incidence of myoclonus (34.37% vs 12.50%) and increased systolic blood pressure, suggesting a trade-off in its use for sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etomidate versus propofol sedation for complex upper endoscopic procedures: a prospective double-blinded randomized controlled trial. Kim, MG., Park, SW., Kim, JH., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024143058

Comparison of efficacy and safety of etomidate with other ... Etomidate seems to offer a minimal beneficial cardiovascular profile in comparison with other agents during induction and intubation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3944222/

Etomidate Use and Postoperative Outcomes among ... Sixty-two percent of 3,127 patients received etomidate. Etomidate recipients had a higher incidence of preoperative congestive heart failure (23.0% vs. 18.3%, p ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7896684/

Etomidate vs propofol in coronary heart disease patients ... In patients with CHD undergoing noncardiac major surgery, etomidate-based anesthesia was associated with fewer cardiovascular events and smaller hemodynamic ...

4. cell.com cell.com/heliyon/pdf/S2405-8440(24)14305-8.pdf

Comparison of efficacy and safety of etomidate with other ... Nevertheless, for patients undergoing cardiac surgery, etomidate seems to offer a minimal beneficial cardiovascular profile in comparison with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06068764

NCT06068764 | Etomidate Versus Propofol in CABG Surgery This information can help inform clinical decision-making and potentially optimize anesthesia management strategies for patients undergoing CABG surgery.