Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2023-12-05
2026-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
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.
Study Groups
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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.
Etomidate
The type of general anesthesia induction agent for CABG surgery
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.
Propofol
The type of general anesthesia induction agent for CABG surgery
Interventions
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Etomidate
The type of general anesthesia induction agent for CABG surgery
Propofol
The type of general anesthesia induction agent for CABG surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
No
Sponsors
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Hartford Hospital
OTHER
Responsible Party
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Joseph Hinchey
Principal Investigator
Principal Investigators
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Joseph Hinchey, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hospital
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Aseel Walker, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HHC-2023-0114
Identifier Type: -
Identifier Source: org_study_id