Preoperative Volume Substitution in Fasting Patients Undergoing Elective Surgery - Impact on Hemodynamic Stability During Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- hemodynamic instability
研究概览
简要总结
Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia.
The purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.
详细描述
The preoperative fasting period often lasts longer than 2 hours as recommended by various national and international anesthetic guidelines. Thus, hypovolemia is more often then anticipated. In awake patients this condition is often masked. Introduction of anesthesia often leads to an unmasking of hypovolemia with a consecutive hemodynamic instability.
Aim of the study is to test the hypothesis that a preoperative volume substitution (8 ml/kg RingerAcetate Solution in 15 min. prior to introduction of anesthesia) reduces possible hemodynamic instabilities during initiation of anesthesia.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •thyreoid, parathyroid or gallbladder surgery
- •general anesthesia
排除标准
- •coronary artery disease
- •congestive heart disease (≥ New York Heart Association (NYHA) 2)
- •insulin dependent diabetes mellitus
- •renal insufficiency (creatinine > 2,0 mg/dl)
- •cerebrovascular disease
- •severe hypertension (≥ antihypertensive drugs)
结局指标
主要结局
hemodynamic instability
时间窗: at time of introduction of anesthesia
Hemodynamic instability during induction of anesthesia (0-10 min), defined as at least one of the following: * Systolic blood pressure \< 80 mmHg or decrease of 20% in preexistent hypertension * Mean blood pressure \< 50 mmHg or decrease of 20% or \> 20 mmHg in preexistent hypertension * Bradycardia \< 45/min or decrease of 20% in preexistent bradycardia \< 60/min. * Tachycardia \> 120/min * Cardiac index \< 2.0 l/min/m²
次要结局
- Enddiastolic area (EDA) > 10 cm2(at time of anesthesia)
- Stroke volume index > 35 ml/m2(at time of anesthesia)
- inferior vana cava diameter (VCI) > 15 mm(at time of anesthesia)
- Stroke volume variation < 12 %(at time of anesthesia)
研究者
Dr. Thomas Kratz
Dr. Thomas Kratz
Philipps University Marburg Medical Center