Etomidate Versus Propofol in CABG Surgery (ETOPRO)

Hartford Hospital

Status and phase: Enrolling; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Propofol; Drug: Etomidate

Study type: Interventional

Funder types: Other

Identifiers

NCT06068764

HHC-2023-0114

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients scheduled for elective open coronary arteries bypass graft CABG surgery
2. Patients with American Society of Anesthesiology (ASA) physical status score I- IV
3. Patients with the ability to speak and read both English and Spanish

Exclusion criteria

1. Emergency CABG surgery, STAT cases, and add-on cases.
2. Refusal or lack of providing the study consent
3. Patients with a known current adrenocortical insufficiency
4. A patient who is presenting with any kind of shock, (e.g. septic, hypovolemic, cardiogenic, etc.)
5. Patients with chronic steroid use (defined as the use of glucocorticoids within 6 months preoperatively)
6. Patients with a known allergy to etomidate or propofol.
7. Patients with a known seizure disorder.
8. Patients who are enrolled in other clinical research studies that can compete with this study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Etomidate

Experimental group

Description:

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.

Treatment:

Drug: Etomidate

Propofol

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol