Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- blood preasure (mean arterial pressure, systolic and diastolic blood pressure)
研究概览
简要总结
Spinal anesthesia is often used for lower limb surgery in elderly. Hypotension is a side effect of spinal block. In this study, intravenous ephedrine and phenylephrine will be compared with each other to prevent spinal anesthesia-induced hypotension, which is defined in absolute terms as a systolic blood pressure < 100 mmHg or in relative terms as a 20% fall of systolic blood pressure from baseline.
详细描述
Randomized single centre clinical randomized study will be performed on 50 participants. The inclusion criteria are participants (age more than 65 years) with proximal femoral fracture scheduled for lower limb surgery under spinal anesthesia.
The Ethics Committee approved this prospective study. Informed consent will be taken from individual subjects. Participants are randomly allocated into one of the two study groups.
Group A: participants who will receive intravenous 25 mg of ephedrine added to syringe with 50 ml 0,9% sodium chloride solution during 20 minutes. Group B: Phenylephrine 5 mg will be added to syringe with 50 ml 0,9% sodium chloride solution, participants will receive intravenous 0,3 mg of phenylephrine during 20 minutes. Randomization is achieved with the help of Random.org.
In order to reduce pain prior to spinal anesthesia an ultrasound-guided fascia iliaca block will be performed using a volume of 30 ml ropivacaine 0,2%. After skin infiltration with 3 ml of lidocaine, a 25G Pencan spinal needle will be inserted at the L3-L4 or L4-L5 vertebral interspaces. After aspirating cerebrospinal fluid, participants will receive hyperbaric bupivacaine 0.5% at 0,11 mg/cm according to the participant height. Ephedrine and phenylephrine will be given intravenous immediately after injection of bupivacaine. Impedance cardiography will be used to measure hemodynamic parameters: cardiac output, stroke volume, cardiac index, stroke index, systemic vascular resistance, systemic vascular resistance index. Heart rate, blood pressure and oxygen saturation will also be controlled. All these parameters will be measured and recorded every 5 minutes until 30 minutes after spinal anesthesia. The data will be statistically analyzed.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elderly (age more than 65 years)
- •hip fracture scheduled for lower limb surgery under spinal anesthesia
- •spinal anesthesia
排除标准
- •contraindications to spinal anesthesia
- •participant refusal
- •age less than 65
- •bradycardia (heart rate less than 60)
- •participants unable to give consent or inability to communicate
研究组 & 干预措施
25 mg of ephedrine
participants who will receive intravenous 1,25mg/min ephedrine during 20 minutes (total dosage is 25 mg of ephedrine).
干预措施: Ephedrine (Drug)
0,3 mg of phenylephrine
participants who will receive intravenous 0,015mg/min phenylephrine during 20 minutes (total dosage is 0,3mg of phenylephrine).
干预措施: Phenylephrine (Drug)
结局指标
主要结局
blood preasure (mean arterial pressure, systolic and diastolic blood pressure)
时间窗: 30 min
parameter will be measured and recorded every 5 min after spinal anesthesia.
次要结局
- heart rate, expressed in bpm(30 min)
- cardiac output, expressed in L/min(30 min)
- stroke volume, expressed in ml(30 min)
- cardiac index, expressed in L/min/m2, is the ratio of cardiac output to the body surface area.(30 min)
- stroke volume variation, expressed in percentage (%)(30 min)
- stroke index, expressed in ml/m2, is the ratio of stroke volume to the body surface area.(30 min)
- systemic vascular resistance, expressed in Dynes.sec.cm-⁵(30 min)
- systemic vascular resistance index, expressed in Dynes.sec.cm-⁵/m2, is the ratio of systemic vascular resistance to the body surface area.(30 min)
- oxygen saturation, expressed in percentage (%)(30 min)
- systemic oxygen delivery, expressed in ml/min(30 min)
研究者
Rafal Kowalczyk
Principal Investigator
Medical University of Warsaw