Etomidate Versus Propofol in CABG Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Etomidate
  The type of general anesthesia induction agent for CABG surgery
• Препарат Propofol
  The type of general anesthesia induction agent for CABG surgery

Первичные конечные точки

• Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min] [Срок оценки: 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.]

Вторичные конечные точки (6)

• The number of incidences of shock [Срок оценки: First 24 hours post anesthesia]
• ICU length of stay [Срок оценки: 3 days]
• Hospital length of stay [Срок оценки: 7 days]
• Hospital Readmissions [Срок оценки: 6 months]
• Time to extubation and end of mechanical ventilation [Срок оценки: until extubation, assessed as 6 hours]
• Incidence of Death [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Hartford Hospital — Hartford

Публикации

• 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
• 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
• 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
• 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
• 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
• 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 rando PMID 19573904
• 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
• 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

Идентификаторы

NCT: NCT06068764 · HHC-2023-0114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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