Etomidate Versus Propofol in CABG Surgery (ETOPRO)

December 27, 2023 updated by: Joseph Hinchey, Hartford Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Hinchey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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).
First 24 hours post anesthesia
ICU length of stay
Time Frame: 3 days
ICU length of stay will be calculated in hours using the ICU data from EPIC.
3 days
Hospital length of stay
Time Frame: 7 days
Hospital length of stay will be calculated in hours from the date and time of admission and discharge, from EPIC.
7 days
Hospital Readmissions
Time Frame: 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.
6 months
Time to extubation and end of mechanical ventilation
Time Frame: until extubation, assessed as 6 hours
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
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: Joseph Hinchey, MD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHC-2023-0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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