Comparison of Methohexital With Propofol for Anesthetic Induction in Patients Treated With an Antagonist of the Renin-Angiotensin System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had Hypotensive Events
研究概览
简要总结
Patient undergoing general anesthesia in elective surgery will be assigned to receive either methohexital or propofol general anesthesia. Hypotensive events during the first 15 minutes of induction will be compared between the groups to ascertain which drug is less likely to cause a hypotensive event.
详细描述
Patients taking angiotensin converting-enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) are susceptible to hypotensive events during general anesthesia. The purpose of this study is to determine if the use of either methohexital or propofol general anesthesias is more likely to result in hypotensive events in these patients during their induction. Hemodynamic metrics like blood pressure, mean arterial pressure, and heart rate will be monitored during the induction process, under both drugs, for use as the main metrics, as well as the need for vasopressors in response to patient hypotension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •treated for at least 6 weeks with ACEIs or ARB
- •undergoing elective surgery under general endotracheal anesthesia
- •ASA Physical Class I or II
排除标准
- •BMI >45kg/m^2
- •taking both ACEI and ARB
- •history of difficult intubation in the past
- •require rapid sequence induction and intubation
- •uncontrolled baseline blood pressure (SBP>180mmHg or DBP >110 mmHg) at anesthesia preoperative clinic visit
- •contraindication to the use of propofol or methohexital
- •significant coronary artery disease
- •history of systolic heart failure
- •history of renal failure (creatine level >2 mg/dL)
研究组 & 干预措施
Methohexital
Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.
干预措施: Methohexital (Drug)
Propofol
Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.
干预措施: Propofol (Drug)
结局指标
主要结局
Number of Participants Who Had Hypotensive Events
时间窗: Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction
Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure
次要结局
- Number of Participants With Refractory Hypotension(Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction)
- Duration of Each Hypotension Episode(Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction)
- Systolic Blood Pressure(Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction)
- Diastolic Blood Pressure(Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction)
- Heart Rate(Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction)
- Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)(Time 0,3,5,10 and 15 min following anesthetic induction)
- Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia)(Time 0,3,5,10 and 15 min following anesthetic induction)
- Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)(Time 0,3,5,10 and 15 min following anesthetic induction)
- Blood Levels of Arginine Vasopressin (AVP) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) for Participants Who Did Not Receive AVP for Refractory Hypotension(Time 0,3,5,10 and 15 min following anesthetic induction)
- Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension(Time 0,3,5,10 and 15 min following anesthetic induction)
研究者
Anthony Bonavia
Assistant Professor
Milton S. Hershey Medical Center