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Etomidate Versus Propofol in CABG Surgery (ETOPRO)

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Etomidate
Propofol
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring CABG surgery, Etomidate, Propofol, general anesthesia induction agenats, cardiothoracic anesthesia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Etomidate

Propofol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
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
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
ICU length of stay will be calculated in hours using the ICU data from EPIC.
Hospital length of stay
Hospital length of stay will be calculated in hours from the date and time of admission and discharge, from EPIC.
Hospital Readmissions
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
Time to extubation, the standard of care is usually within 6 hours of arriving to the unit.
Incidence of Death
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.

Full Information

First Posted
August 10, 2023
Last Updated
September 28, 2023
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06068764
Brief Title
Etomidate Versus Propofol in CABG Surgery
Acronym
ETOPRO
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG surgery, Etomidate, Propofol, general anesthesia induction agenats, cardiothoracic anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective, single-blinded, randomized controlled clinical trial
Masking
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.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Etomidate
Arm Type
Experimental
Arm Description
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.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etomidate
Other Intervention Name(s)
Amidate™
Intervention Description
The type of general anesthesia induction agent for CABG surgery
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
The type of general anesthesia induction agent for CABG surgery
Primary Outcome Measure Information:
Title
Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
Description
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.
Time Frame
30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.
Secondary Outcome Measure Information:
Title
The number of incidences of shock
Description
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).
Time Frame
First 24 hours post anesthesia
Title
ICU length of stay
Description
ICU length of stay will be calculated in hours using the ICU data from EPIC.
Time Frame
3 days
Title
Hospital length of stay
Description
Hospital length of stay will be calculated in hours from the date and time of admission and discharge, from EPIC.
Time Frame
7 days
Title
Hospital Readmissions
Description
In the 6th month after surgery, a retrospective safety checkup will be done, using EPIC chart review, to assess the number of readmissions.
Time Frame
6 months
Title
Time to extubation and end of mechanical ventilation
Description
Time to extubation, the standard of care is usually within 6 hours of arriving to the unit.
Time Frame
until extubation, assessed as 6 hours
Title
Incidence of Death
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aseel Walker, MD
Phone
860-972-1778
Email
Aseel.Walker@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Hinchey, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aseel Walker, MD
Phone
860-972-1778
Email
aseel.walker@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Joseph Hinchey, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Etomidate Versus Propofol in CABG Surgery

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