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

Trial Summary

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 data supports the effectiveness of the drugs Etomidate and Propofol for anesthesia in coronary artery disease surgery?

Research suggests that both Etomidate and Propofol are considered superior to other anesthetic agents for patients with coronary artery disease and left ventricular dysfunction, as they help maintain stable blood pressure and heart function during surgery. ^{1 2 3 4 5}

Is it safe to use Etomidate and Propofol for anesthesia in coronary artery disease surgery?

Both Etomidate and Propofol have been studied for their safety in anesthesia. Etomidate is noted for providing stability in heart and breathing functions, even in high-risk patients, while Propofol can cause heart and breathing issues but is generally considered safe when used carefully. ^{2 3 6 7 8}

How does the drug Etomidate-Propofol differ from other drugs for coronary artery disease surgery?

Etomidate and Propofol are used together for anesthesia in coronary artery disease surgery because they are less likely to cause harmful changes in blood pressure and heart function compared to other drugs. This combination is particularly beneficial for patients with weakened heart function, as it helps maintain stable heart performance during surgery. ^{1 3 4 5 9}

What is the purpose of this trial?

The objective of this single-blinded randomized controlled interventional clinical trial is to learn about the efficacy and long-term safety of etomidate compared to propofol as an anesthesia induction agent in patients undergoing coronary artery bypass graft (CABG) surgery. The primary aim of this study is to determine whether patients receiving etomidate or propofol exhibit similar requirements for vasopressor or ionotropic agents during both the intraoperative and postoperative periods. To achieve this goal, participants who are scheduled for CABG surgery will be randomly assigned to receive either etomidate or propofol as the principal hypnotic agent. The researchers will then compare the effects of these two anesthesia induction agents on various factors, including the need for hemodynamic support, hemodynamic stability, duration of mechanical ventilation, length of stay in the intensive care unit (ICU), and overall hospital length of stay. Additionally, they will assess whether there are disparities in mortality rates and readmission rates within a 6-month timeframe after the surgery. By comparing the outcomes between the two groups, the study aims to provide valuable insights into the potential differences in vasopressor or ionotropic agent requirements between etomidate and propofol. This information can help inform clinical decision-making and potentially optimize anesthesia management strategies for patients undergoing CABG surgery.

Research Team

Joseph Hinchey, MD

Principal Investigator

Hartford Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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 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]

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 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]

References

1. India pubmed.ncbi.nlm.nih.gov

A randomized trial of anesthetic induction agents in patients with coronary artery disease and left ventricular dysfunction. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

[A comparative study between propofol and etomidate in patients under general anesthesia]. [2016]

3. Bosnia and Herzegovina 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. [2019]

4. Switzerland 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. [2021]

5. Poland 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. [2020]

6. Brazil pubmed.ncbi.nlm.nih.gov

A comparative study between propofol and etomidate in patients under general anesthesia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Etomidate versus propofol sedation for complex upper endoscopic procedures: a prospective double-blinded randomized controlled trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Etomidate and the Risk of Complications After Cardiac Surgery: A Retrospective Cohort Analysis. [2017]

9. United States 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. [2022]