Etomidate Versus Propofol in CABG Surgery

NCT06068764 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HHC-2023-0114
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.

Secondary Outcomes (6)

• The number of incidences of shock

  First 24 hours post anesthesia

• ICU length of stay

  3 days

• Hospital length of stay

  7 days

• Hospital Readmissions

  6 months

• Time to extubation and end of mechanical ventilation

  until extubation, assessed as 6 hours

Study Arms (2)

Etomidate

EXPERIMENTAL

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

Propofol

ACTIVE COMPARATOR

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

Interventions

Etomidate DRUG

The type of general anesthesia induction agent for CABG surgery

Also known as: Amidate™

Etomidate

Propofol DRUG

The type of general anesthesia induction agent for CABG surgery

Also known as: Diprivan

Propofol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

Related Publications (15)

• Hildreth AN, Mejia VA, Maxwell RA, Smith PW, Dart BW, Barker DE. Adrenal suppression following a single dose of etomidate for rapid sequence induction: a prospective randomized study. J Trauma. 2008 Sep;65(3):573-9. doi: 10.1097/TA.0b013e31818255e8.

  PMID: 18784570 BACKGROUND

• De Jong A, Jaber S. Etomidate for anesthesia induction: friends or foe in major cardiac surgery? Crit Care. 2014 Oct 10;18(5):560. doi: 10.1186/s13054-014-0560-7.

  PMID: 25672223 BACKGROUND

• Ledingham IM, Watt I. Influence of sedation on mortality in critically ill multiple trauma patients. Lancet. 1983 Jun 4;1(8336):1270. doi: 10.1016/s0140-6736(83)92712-5. No abstract available.

  PMID: 6134053 BACKGROUND

• Chan CM, Mitchell AL, Shorr AF. Etomidate is associated with mortality and adrenal insufficiency in sepsis: a meta-analysis*. Crit Care Med. 2012 Nov;40(11):2945-53. doi: 10.1097/CCM.0b013e31825fec26.

  PMID: 22971586 BACKGROUND

• Erdoes G, Basciani RM, Eberle B. Etomidate--a review of robust evidence for its use in various clinical scenarios. Acta Anaesthesiol Scand. 2014 Apr;58(4):380-9. doi: 10.1111/aas.12289. Epub 2014 Mar 3.

  PMID: 24588359 BACKGROUND

• Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.

  PMID: 19573904 BACKGROUND

• McPhee LC, Badawi O, Fraser GL, Lerwick PA, Riker RR, Zuckerman IH, Franey C, Seder DB. Single-dose etomidate is not associated with increased mortality in ICU patients with sepsis: analysis of a large electronic ICU database. Crit Care Med. 2013 Mar;41(3):774-83. doi: 10.1097/CCM.0b013e318274190d.

  PMID: 23318491 BACKGROUND

• Hohl CM, Kelly-Smith CH, Yeung TC, Sweet DD, Doyle-Waters MM, Schulzer M. The effect of a bolus dose of etomidate on cortisol levels, mortality, and health services utilization: a systematic review. Ann Emerg Med. 2010 Aug;56(2):105-13.e5. doi: 10.1016/j.annemergmed.2010.01.030. Epub 2010 Mar 25.

  PMID: 20346542 BACKGROUND

• Wagner CE, Bick JS, Johnson D, Ahmad R, Han X, Ehrenfeld JM, Schildcrout JS, Pretorius M. Etomidate use and postoperative outcomes among cardiac surgery patients. Anesthesiology. 2014 Mar;120(3):579-89. doi: 10.1097/ALN.0000000000000087.

  PMID: 24296761 BACKGROUND

• Heinrich S, Schmidt J, Ackermann A, Moritz A, Harig F, Castellanos I. Comparison of clinical outcome variables in patients with and without etomidate-facilitated anesthesia induction ahead of major cardiac surgery: a retrospective analysis. Crit Care. 2014 Jul 11;18(4):R150. doi: 10.1186/cc13988.

  PMID: 25015112 BACKGROUND

• Basciani RM, Rindlisbacher A, Begert E, Brander L, Jakob SM, Etter R, Carrel T, Eberle B. Anaesthetic induction with etomidate in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jun;33(6):417-24. doi: 10.1097/EJA.0000000000000434.

  PMID: 26914224 BACKGROUND

• Morel J, Salard M, Castelain C, Bayon MC, Lambert P, Vola M, Auboyer C, Molliex S. Haemodynamic consequences of etomidate administration in elective cardiac surgery: a randomized double-blinded study. Br J Anaesth. 2011 Oct;107(4):503-9. doi: 10.1093/bja/aer169. Epub 2011 Jun 17.

  PMID: 21685487 BACKGROUND

• Iribarren JL, Jimenez JJ, Hernandez D, Lorenzo L, Brouard M, Milena A, Mora ML, Martinez R. Relative adrenal insufficiency and hemodynamic status in cardiopulmonary bypass surgery patients. A prospective cohort study. J Cardiothorac Surg. 2010 Apr 19;5:26. doi: 10.1186/1749-8090-5-26.

  PMID: 20403156 BACKGROUND

• Hannam JA, Mitchell SJ, Cumin D, Frampton C, Merry AF, Moore MR, Kruger CJ. Haemodynamic profiles of etomidate vs propofol for induction of anaesthesia: a randomised controlled trial in patients undergoing cardiac surgery. Br J Anaesth. 2019 Feb;122(2):198-205. doi: 10.1016/j.bja.2018.09.027. Epub 2018 Nov 15.

  PMID: 30686305 BACKGROUND

• Goradia S, Sardaneh AA, Narayan SW, Penm J, Patanwala AE. Vasopressor dose equivalence: A scoping review and suggested formula. J Crit Care. 2021 Feb;61:233-240. doi: 10.1016/j.jcrc.2020.11.002. Epub 2020 Nov 14.

  PMID: 33220576 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Etomidate; Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Joseph Hinchey, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aseel Walker, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center, prospective, single-blinded, randomized controlled clinical trial

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: October 5, 2023
• Study Start: December 5, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)