NCT06068764 · Hartford Hospital
Etomidate Versus Propofol in CABG Surgery
(ETOPRO)
What this study is about
The objective of this single-blinded randomly assigned controlled interventional clinical trial is to learn about the effectiveness and long-term safety of etomidate compared to propofol as an anesthesia induction agent in patients undergoing coronary artery bypass graft (CABG) surgery.
View original scientific description
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.
Interventions
DRUG
Etomidate
The type of general anesthesia induction agent for CABG surgery
DRUG
Propofol
The type of general anesthesia induction agent for CABG surgery
Primary outcome measures
Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
Time frame: 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.
Vasopressor requirements will be expressed as Noradrenaline Equivalent dose using the formula of (NEq \[μg/kg/min\] = norepinephrine + epinephrine + phenylephrine/10 + dopamine/100 + vasopressin\*2.5), this will be measured during three periods of time: Intraoperatively during the first 30 minutes post induction (as a reflection of the impact of induction on hemodynamics), intraoperatively during the last 30 minutes of the post bypass period, and for the first 24 hours post procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients scheduled for elective open coronary arteries bypass graft CABG surgery
- Patients with American Society of Anesthesiology (ASA) physical status score I- IV
- Patients with the ability to speak and read both English and Spanish
Exclusion criteria
- Emergency CABG surgery, STAT cases, and add-on cases.
- Refusal or lack of providing the study consent
- Patients with a known current adrenocortical insufficiency
- A patient who is presenting with any kind of shock, (e.g. septic, hypovolemic, cardiogenic, etc.)
- Patients with chronic steroid use (defined as the use of glucocorticoids within 6 months preoperatively)
- Patients with a known allergy to etomidate or propofol.
- Patients with a known seizure disorder.
- Patients who are enrolled in other clinical research studies that can compete with this study.
Where
- Hartford, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 28, 2023 · Source of record for eligibility and locations