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NCT Number: NCT06068764

Etomidate Versus Propofol in CABG Surgery

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location status: Recruiting

Location contact

Aseel Walker, MD

CONTACT

[email protected]

860-972-1778

Joseph Hinchey, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etomidate

Drug

The type of general anesthesia induction agent for CABG surgery

Other names: Amidate™

Propofol

Drug

The type of general anesthesia induction agent for CABG surgery

Other names: Diprivan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. ICU length of stay

    Time frame: 3 days

    ICU length of stay will be calculated in hours using the ICU data from EPIC.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aseel Walker, MD

CONTACT

[email protected]

860-972-1778

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

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

Acronym: ETOPRO

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 5, 2023
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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