Etomidate Versus Propofol in CABG Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Etomidate Versus Propofol As An Anesthesia Induction Agent For Patients Undergoing CABG Surgery, Assessing Hemodynamic Stability. A Single Blinded, Randomized Controlled Trial.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Etomidate
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, prospective, single-blinded, randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etomidate<br>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. | Drug: Etomidate<br>* The type of general anesthesia induction agent for CABG surgery<br>* Other names: Amidate™;|
| Active Comparator: Propofol<br>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. | Drug: Propofol<br>* The type of general anesthesia induction agent for CABG surgery<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min] | 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. | 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidences of shock | The incidence of both vasogenic and cardiogenic shocks will be determined intraoperatively and postoperatively using the Mean Arterial Pressure (MAP), Central Venous Pressure (CVP), Cardiac Output (CO), and Systemic Vascular Resistance (SVR). Vasogenic shock (defined as a MAP < 60 mmHg with normal CO (>2.0 L/min) and low SVR (< 900 dynes/sec). Cardiogenic shock (defined as hypotension with MAP < 60 mmHg, low CO (<2.0 L/min), and normal SVR range (900-1400 dynes/sec). | First 24 hours post anesthesia | 
| ICU length of stay | ICU length of stay will be calculated in hours using the ICU data from EPIC. | 3 days | 
| Hospital length of stay | Hospital length of stay will be calculated in hours from the date and time of admission and discharge, from EPIC. | 7 days | 
| Hospital Readmissions | In the 6th month after surgery, a retrospective safety checkup will be done, using EPIC chart review, to assess the number of readmissions. | 6 months | 
| Time to extubation and end of mechanical ventilation | Time to extubation, the standard of care is usually within 6 hours of arriving to the unit. | until extubation, assessed as 6 hours | 
| Incidence of Death | In the 6th month after surgery, a retrospective safety checkup will be done, using EPIC chart review, to assess the number of deaths if any. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG surgery, Etomidate, Propofol, general anesthesia induction agenats, cardiothoracic anesthesia