Anesthesia Comparison for Coronary Artery Disease Surgery
(ETOPRO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Hartford Hospital
Must not be taking: Chronic steroids
Disqualifiers: Adrenocortical insufficiency, Shock, Seizure, others
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.
12345Is 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.
23678How 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.
13459Eligibility 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.
+5 more
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hartford HospitalHartford, CT
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Who Is Running the Clinical Trial?
Hartford HospitalLead Sponsor
References
A randomized trial of anesthetic induction agents in patients with coronary artery disease and left ventricular dysfunction. [2022]The deleterious effects of anesthetic agents in patients suffering from coronary artery disease are well known. The risk increases when a patient has compromised ventricular function. There is a paucity of literature regarding the choice of the suitable agent to avoid deleterious effects in such patients. The use of etomidate and propofol has been considered superior to other intravenous anesthetic agents in these groups of patients. The aim of the present study is to compare the hemodynamic effects of anesthesia induction with etomidate, thiopentone, propofol, and midazolam in patients with coronary artery disease and left ventricular dysfunction. This randomized clinical trail was conducted at the All Indian Institute of Medical Sciences, New Delhi, India. Sixty patients with coronary artery disease and left ventricular dysfunction (ejection fraction
[A comparative study between propofol and etomidate in patients under general anesthesia]. [2016]Induction of anesthesia is a critical part of anesthesia practice. Sudden hypotension, arrhythmias, and cardiovascular collapse are threatening complications following injection of induction agent in hemodynamically unstable patients. It is desirable to use a safe agent with fewer adverse effects for this purpose. Present prospective randomized study is designed to compare propofol and etomidate for their effect on hemodynamics and various adverse effects on patients in general anesthesia.
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]Anesthesia induction is often accompanied by a period of hemodynamic instability, which could be deleterious in patients with coronary artery disease (CAD) and left ventricular dysfunction undergoing coronary artery bypass graft (CABG) surgery. The aim of this study was to compare the hemodynamic responses to propofol, etomidate, and diazepam following anesthesia induction, laryngoscopy and intubation in CABG surgery patients with low ejection fraction (EF).
Infectious Complications after Etomidate vs. Propofol for Induction of General Anesthesia in Cardiac Surgery-Results of a Retrospective, before-after Study. [2021]Etomidate is typically used as an induction agent in cardiac surgery because it has little impact on hemodynamics. It is a known suppressor of adrenocortical function and may increase the risk for post-operative infections, sepsis, and mortality. The aim of this study was to evaluate whether etomidate increases the risk of postoperative sepsis (primary outcome) and infections (secondary outcome) compared to propofol.
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]Anesthesia induction is often accompanied by a period of hemodynamic instability, which could be a significant problem in patients with compromised ventricular function. The aim of this study is to compare the hemodynamic responses to etomidate versus a combination of ketamine and propofol (ketofol) for anesthetic induction in patients with left ventricular dysfunction undergoing coronary artery bypass graft (CABG) surgery.
A comparative study between propofol and etomidate in patients under general anesthesia. [2022]Induction of anesthesia is a critical part of anesthesia practice. Sudden hypotension, arrhythmias, and cardiovascular collapse are threatening complications following injection of induction agent in hemodynamically unstable patients. It is desirable to use a safe agent with fewer adverse effects for this purpose. Present prospective randomized study is designed to compare propofol and etomidate for their effect on hemodynamics and various adverse effects on patients in general anesthesia.
Etomidate versus propofol sedation for complex upper endoscopic procedures: a prospective double-blinded randomized controlled trial. [2018]Although a growing body of evidence demonstrates that propofol-induced deep sedation can be effective and performed safely, cardiopulmonary adverse events have been observed frequently. Etomidate is a new emerging drug that provides hemodynamic and respiratory stability, even in high-risk patient groups. The objective of this study was to compare safety and efficacy profiles of etomidate and propofol for endoscopic sedation.
Etomidate and the Risk of Complications After Cardiac Surgery: A Retrospective Cohort Analysis. [2017]To compare incidence of atrial arrhythmia, duration of care, and major complications after cardiac surgery between patients who received etomidate and those who received other induction agents.
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]BACKGROUND Volatile anesthesia possesses cardioprotective properties, and it is widely used in patients undergoing coronary artery bypass surgery, but no randomized controlled trials (RCTs) are available on the use of sevoflurane-remifentanil versus propofol-remifentanil anesthesia for patients with coronary artery disease (CAD) during noncardiac surgery. This study was designed to compare the 2 different types of general anesthesia in patients with CAD undergoing noncardiac surgery at a single center. MATERIAL AND METHODS Patients with CAD undergoing noncardiac surgery were enrolled in an RCT conducted between March 2016 and December 2017. The participants were randomized to receive either sevoflurane-remifentanil or propofol-remifentanil anesthesia. The primary endpoint was occurrence of in-hospital cardiovascular events. The secondary endpoints included delirium, postoperative nausea and vomiting (PONV), Intensive Care Unit (ICU) length of stay (LOS), in-hospital morbidity and mortality, and hospital LOS. RESULTS A total of 164 participants completed the study (sevoflurane: 81; propofol: 83). The occurrence of in-hospital cardiovascular events did not differ between the 2 groups (42.6% vs 39.4%, P=0.86). The occurrence of delirium did not differ between the 2 groups after the operation. PONV had a higher frequency after sevoflurane anesthesia at 48 h compared with propofol. In-hospital morbidity and mortality, ICU LOS, and hospital LOS were similar between the 2 groups (all P>0.05). At 30 days after surgery, no between-group differences in cardiac morbidity and mortality were observed. CONCLUSIONS In this study, anesthesia using sevoflurane-remifentanil did not provide additional postoperative cardioprotection in comparison with propofol-remifentanil in patients with CAD undergoing noncardiac surgery.