Clinical trial NCT06068764: Etomidate Versus Propofol in CABG Surgery
Official title: Etomidate Versus Propofol As An Anesthesia Induction Agent For Patients Undergoing CABG Surgery, Assessing Hemodynamic Stability. A Single Blinded, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: CABG surgery
Etomidate
Propofol
general anesthesia induction agenats
cardiothoracic anesthesia
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, single-blinded, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
timeFrame: 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.
Secondary outcomes:
measure: The number of incidences of shock
timeFrame: First 24 hours post anesthesia
measure: ICU length of stay
timeFrame: 3 days
measure: Hospital length of stay
timeFrame: 7 days
measure: Hospital Readmissions
timeFrame: 6 months
measure: Time to extubation and end of mechanical ventilation
timeFrame: until extubation, assessed as 6 hours
measure: Incidence of Death
timeFrame: 6 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Joseph Hinchey, MD
role: PRINCIPAL_INVESTIGATOR
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