ETOPRO: Etomidate Versus Propofol in CABG Surgery

Sponsor

Hartford Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06068764

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Etomidate Drug: Propofol	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-center, prospective, single-blinded, randomized controlled clinical trialSingle-center, prospective, single-blinded, randomized controlled clinical trial

Masking:

Single (Participant)

Masking Description:

Due to the difference in the physical appearance of etomidate and propofol medications, the anesthesiologist administering any of these medications will not be blinded. Only study patients will be blinded to the anesthesia induction agent they receive. Therefore, this study is considered single-blinded. Since this is a clinical trial, blinding is an important method to reduce bias and ensure the validity of study results. Unblinding is unnecessary in this study unless the situation when a participant experiences a serious adverse event that is unexpected and related to the anesthesia induction agent (study intervention) and the course of treatment needs to be adjusted. Unblinding in this situation will be the decision of the principal investigator (PI). The PI will unblind the patient (i.e., tell the patient about the assigned group), and take any additional necessary course of treatment.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etomidate 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 The type of general anesthesia induction agent for CABG surgery Other Names: Amidate™
Active Comparator: Propofol 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 The type of general anesthesia induction agent for CABG surgery Other Names: Diprivan

Arm

Intervention/Treatment

Experimental: Etomidate

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

The type of general anesthesia induction agent for CABG surgery

Other Names:

Amidate™

Active Comparator: Propofol

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

The type of general anesthesia induction agent for CABG surgery

Other Names:

Diprivan

Outcome Measures

Primary Outcome Measures

Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min] [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.

Secondary Outcome Measures

The number of incidences of shock [First 24 hours post anesthesia]
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).
ICU length of stay [3 days]
ICU length of stay will be calculated in hours using the ICU data from EPIC.
Hospital length of stay [7 days]
Hospital length of stay will be calculated in hours from the date and time of admission and discharge, from EPIC.
Hospital Readmissions [6 months]
In the 6th month after surgery, a retrospective safety checkup will be done, using EPIC chart review, to assess the number of readmissions.
Time to extubation and end of mechanical ventilation [until extubation, assessed as 6 hours]
Time to extubation, the standard of care is usually within 6 hours of arriving to the unit.
Incidence of Death [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.