Etomidate Versus Propofol As An Anesthesia Induction Agent For Patients Undergoing CABG Surgery, Assessing Hemodynamic Stability. A Single Blinded, Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Etomidate (Drug)
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.
干预措施: Propofol (Drug)
结局指标
主要结局
Vasopressors dose expressed by Noradrenaline Equivalent dose [μg/kg/min]
时间窗: 30 minutes after induction, last 30 minutes of post bypass period, and first 24 hours post procedure.
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.
次要结局
- ICU length of stay(3 days)
- The number of incidences of shock(First 24 hours post anesthesia)
- Time to extubation and end of mechanical ventilation(until extubation, assessed as 6 hours)
- Hospital length of stay(7 days)
- Hospital Readmissions(6 months)
- Incidence of Death(6 months)
研究者
Joseph Hinchey
Principal Investigator
Hartford Hospital