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临床试验/NCT02178774
NCT02178774Unknown不适用

Using Non-invasive Near-infrared Spectroscopy and Color Doppler to Evaluate the Relationship Between the Perfusion of Uterus and Gastrocnemius Muscles of the Parturients Receiving Cesarean Section

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
tissue oxygen saturation

研究概览

简要总结

Hypotension after spinal anesthesia for cesarean section is one of the most common perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower extremities and an increase in venous capacitance. Hypotension is a distress for both anesthesiologists and obstetricians as it endangers parturient's hemodynamics and compromises the uteroplacental blood flow. In clinical practice, there are several ways to treat hypotension after spinal anesthesia such as preloading with intravenous fluids and administrating ephedrine. Normotensive maternal blood pressure does neither guarantee the well-being of the fetus nor ensure the tissue perfusion of the parturient. Based on the anatomy and physiology basis, we hypothesize that uterine perfusion under spinal anesthesia would correlate with the perfusion of the lower extremities. To measure the perfusion of the lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared spectroscopy.

详细描述

This is a prospective observational study. Parturients who are going to receive an elective cesarean section will be enrolled. Before entering the operating rooms, the parturient enrolled receives the Doppler studies. The external iliac artery is identified and color Doppler is activated to locate the uterine artery crossed the external iliac artery. The probe is stabilized to obtain the maximum flow velocity waveform.The pulsatility index of these three waveforms is calculated and recorded as the baseline. Three minutes after the anesthetics are injected, the same procedures of color Doppler are performed again, and the PI after the spinal anesthesia is recorded.

Tissue (cerebral) oximeter (INVOS Cerebral Oximeter Model 5100B; Somanetics, Troy, MI, USA) is used for the NIRS technique. Two adhesive sensor patches are attached to the parturient. One sensor patch is applied over the the biceps brachii of the upper limb while the other adhere to the medial side of the gastrocnemius muscle. After the oximeter shows a stable reading, the baseline data are recorded. The parturient then receive spinal anesthesia in the right lateral decubitus position. The intrathecal injection consists of 0.5% hyperbaric bupivacaine. NIBP is monitored at 2.5 minutes interval for 30 minutes. Tissue oximeter starts recording every minute right after local anesthetics are injected into the intrathecal space for a total of fifteen minutes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Parturients
  • elective cesarean section
  • ASA class I or class II

排除标准

  • Emergent cesarean section
  • Skin lesions over the site of local anesthetic injection
  • Skin lesions over the sites where NIRS patches are about to be attached
  • Patients with history of being allergic to NIRS patches
  • Patients with coagulopathy or other contraindications for spinal anesthesia

结局指标

主要结局

tissue oxygen saturation

时间窗: Tissue oximeter starts recording before and every minute right after local anesthetics are injected into the intrathecal space for a total of fifteen minutes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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