Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Incidence of severe blood pressure drops
研究概览
简要总结
The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery.
详细描述
40 individuals are enrolled to the study after signed informed consent at the day of surgery. The study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg LBW, Gelofusine™, Fresenius Kabi AB, Sweden) or control (no preoperative fluids) before standardized TCI- induction of anesthesia. No other intravenous fluids before anesthesia induction.
Preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •age over 18 years
- •body mass index ≤ 35 kg/m2
- •electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery
排除标准
- •instable angina pectoris
- •severe bronchial asthma
- •severe COPD
- •severe heart valve disease
- •severe renal failure
- •body mass index > 35 kg/m2
结局指标
主要结局
Incidence of severe blood pressure drops
时间窗: 20 minutes post anesthesia induction
Blood pressure drop below mean arterial pressure at 55 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction.
Incidence of blood pressure drops
时间窗: 20 minutes post anesthesia induction
Blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction .
次要结局
- Diastolic dysfunction and hemodynamic stability(20 minutes post anesthesia induction)
- Venous return and hemodynamic stability(20 minutes post anesthesia induction)
- Systolic heart failure and hemodynamic stability(20 minutes post anesthesia induction)
研究者
Tomi Myrberg
Principal investigator
Umeå University