Recruiting

Etomidate vs. Propofol

Sponsor:

Hartford Hospital

Code:

NCT06068764

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Etomidate

Propofol

Study Details

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.

Conditions

Coronary Artery Disease

Study ID

NCT06068764

Start date

Dec 5, 2023

Status verified date

Dec, 2023

Completion date

Aug, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Etomidate

The type of general anesthesia induction agent for CABG surgery

Propofol

The type of general anesthesia induction agent for CABG surgery

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Aseel Walker, MD

860-972-1778Aseel.Walker@hhchealth.org

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Aseel Walker, MD

860-972-1778aseel.walker@hhchealth.org

Principal Investigator:

Joseph Hinchey, MD

More Information

Sponsor

Hartford Hospital

Last update posted

Dec 28, 2023

Last verified

Dec, 2023

Keywords

  • CABG surgery
  • Etomidate
  • Propofol
  • general anesthesia induction agenats
  • cardiothoracic anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2023-12-28.