Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section: Randomized, Prospective Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- hemodynamic continuous monitoring by impedance cardiography
研究概览
简要总结
Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring. Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing elective cesarean section; secondary, to compare the duration and quality of analgesia and anesthesia
详细描述
On arrival in the recovery room the ICG non-invasive blood pressure cuff will be placed on the left arm, two sensors will be placed above the clavicle on each side of the neck, and two sensors will bw placed on either side of the thorax at midaxillary line corresponding to the level of the xiphoid process. Using a computer- generated sequence of numbers, patients will be randomly allocated in one of the two groups: 6 mg (1.6 mL) levobupivacaine + 20 µg fentanyl (GL6 group) or 8 mg (2 mL) levobupivacaine + 20 µg fentanyl (GL8 group). Continuous spinal epidural anesthesia (CSE) will be performed with patient in sitting position: a 18-gauge Tuohy needle will be inserted into the L2-L3 interspace using the loss of resistance of saline technique to identify the epidural space; a 27-gauge Withacre spinal needle will be then placed through the Tuohy needle until the dura mater wwill be punctured and isobaric undiluted levobupivacaine plus 20 µg fentanyl was administered. Afterwards, an epidural catheter (Espocan, B.Braun, Melsungen, Germany) wwill be inserted 4 cm into the epidural space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant undergoing elective Caesarean delivery at term of singleton pregnancy, with American Society of Anesthesiologists physical status of class I or II, without preeclampsia or diabetes,
排除标准
- •Patient with a known allergy to amide local anesthetics and other drugs, with BMI≥40 kg/m2, cardiologic or systemic disease, in treatment with antihypertensive or anticoagulant
研究组 & 干预措施
8 mg (2 mL) levobupivacaine
8mg (2ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Impedance cardiography (Device)
8 mg (2 mL) levobupivacaine
8mg (2ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Sensory levels (Diagnostic Test)
8 mg (2 mL) levobupivacaine
8mg (2ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Motor block (Diagnostic Test)
8 mg (2 mL) levobupivacaine
8mg (2ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Sensory level (Diagnostic Test)
6 mg (1.6 mL) levobupivacaine
6mg (1.6ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Impedance cardiography (Device)
6 mg (1.6 mL) levobupivacaine
6mg (1.6ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Sensory levels (Diagnostic Test)
6 mg (1.6 mL) levobupivacaine
6mg (1.6ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Motor block (Diagnostic Test)
6 mg (1.6 mL) levobupivacaine
6mg (1.6ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
干预措施: Sensory level (Diagnostic Test)
结局指标
主要结局
hemodynamic continuous monitoring by impedance cardiography
时间窗: intraoperative time
Impedance cardiography as a tool for hemodynamic monitoring during cesarean section
次要结局
- onset of sensory block(intraoperative time)
- offset of motor block(intraoperative time)
- offset of sensory block(intraoperative time)
- onset of motor block(intraoperative time)
研究者
Cotoia Antonella
researcher
University of Foggia