Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The level of systemic vascular resistance
研究概览
简要总结
Ephedrine is commonly clinically vasoactive drugs, which can constrict blood vessels and increase blood pressure. Ephedrine can not only stimulate α receptors, but also β receptors, that's to say, it can increase heart rate, stroke volume, and cardiac output, but it also can decrease the level of systemic vascular resistance. This research aims to observe the short-term vasodilator effect of diffierent doses of ephedrine used in elderly patients under general anesthesia in clinical practice, and analyze the main reasons for this phenomenon and take preventive actions to minimize the possibility of further lowering of blood pressure to provide references for clinical rational use of drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages ranged from 65 to 80
- •ASA I~II
- •patients undergoing elective general anesthesia
- •BMI 18.5-30.0
排除标准
- •refusal of patients
- •emergency surgery, neurological or mental disorders , Liver and kidney dysfunction
- •previous allergy to ephedrine and phenylephrine
- •heart disease history, such as pacemaker implantation, unstable angina, congestive heart failure, Heart valve disease
- •nerve, digestive, endocrine system diseases, and affect intravascular Fluid volume or balance diseases (such as inflammatory diseases or gastrointestinal obstructive diseases)
- •emergency surgery
- •malignant tumors
- •tachycardia (HR>100)
- •bradycardia ( HR<50)
- •intraoperative hypotension that is difficult to correct with ephedrine and phenylephrine
- •use of other vasoactive drugs.
- •surgery time <40 min
研究组 & 干预措施
ephedrine (4mg)
干预措施: Ephedrine (Drug)
ephedrine (8mg)
干预措施: Ephedrine (Drug)
ephedrine (12mg)
干预措施: Ephedrine (Drug)
结局指标
主要结局
The level of systemic vascular resistance
时间窗: during surgery to 30 minutes after being sent to the PACU
The outcomes above should be measured at Immediately after the injection of the drug (T1), 30s after the injection (T2), 1 min after the injection(T3), 1 min30 s after the injection(T4), 2 min after the injection(T5), 2 min30s after the injection(T6), 3 min after the injection(T7), 3 min30s after the injection( T8), 4 min after the injection(T9), 4 min30s after the injection(T10), 5 min after the injection(T11), immediately after surgery (T12), 30 min in PACU (T13)
次要结局
- The level of cardiac index(during surgery to 30 minutes after being sent to the PACU)
- The level of heart rate cardiac circulation efficiency(during surgery to 30 minutes after being sent to the PACU)
- The level of cardiac output(during surgery to 30 minutes after being sent to the PACU)
- The level of maximum pressure gradient(during surgery to 30 minutes after being sent to the PACU)
- The level of heart rate(during surgery to 30 minutes after being sent to the PACU)
- The amount of infusion volume,propofol and remifentanil(intraoperative)
- The level of mean arterial pressure(during surgery to 30 minutes after being sent to the PACU)
- The occurrence of adverse events about the cardiovascular system(from the beginning of the surgery to 30 minutes after being sent to the PACU)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University