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临床试验/NCT04345822
NCT04345822Unknown不适用

Effect of Cervical Compressive Myelopathy on the Autonomic Nervous System and Clinical Implication

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
change of hear rate variability

研究概览

简要总结

Myelopathy from cervical cord compression may induce hypertension and sympathetic hyperactivity. Anesthesia may suppress sympathetic activity and lead to hypotension that require vasopressor treatment. We aim to elucidate the causative factors for severe hypotension during anesthesia by prospective observational study.

详细描述

It had been reported the cervical spondylotic myelopathy may lead to the development of hypertension. Decompression surgeries ameliorated neurological symptoms as well as the blood pressure. The cause may be the abnormality of autonomic dysfunction developed after myelopathy. However, the evidence was weak. We have noticed a tendency of hypotension during anesthesia in patients undergroing cervical spine surgeries, especially in surgeries of long levels and hypertensive patients. Thus we postulate the autonomic activity is abnormal in patients with cervical myelopathy. Sympathetic hyperactivity developed in order to maintain adequate perfusion to the cervical cord. When patients are under anesthesia, the sympathetic tone is suppressed, thus leading to severe hypotension that require the treatment of inotropic treatment. Heart rate variability (HRV) is a good index of autonomic activity. Thus we plan to Therefore we will measure the HRV (analysis of ECG) and baroreflex activity (analysis of arterial line during the anesthesia) in patients undergoing cervical spine surgeries for decompression of cord compression perioperatively. The primary end-point is the comparison of severity of cord compression between normotensive and hypertensive patients with cervical myelopathy. The secondary end-point is to compare blood pressure and HRV pre- and postoperatively. The third end-point is to elucidate the causative factors for severe hypotension during anesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cervical spine surgery for cord compression

排除标准

  • spinal cord injury
  • ASA class >3
  • chronic kidney disease
  • congestive heart failure
  • atrial fibrillation/ flutter
  • obstructive sleep apnea

结局指标

主要结局

change of hear rate variability

时间窗: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery

from analysis of ECG

change of blood pressure

时间窗: one day before surgery, during surgery, 3 months after surgery, 6 months after surgery

noninvasive blood pressure

baroreflex activity

时间窗: during surgery (anesthesia)

from analysis of arterial blood pressure waveform

次要结局

  • change of the Nurick scores(one day before surgery, 3 months after surgery, 6 months after surgery)
  • change of Japanese Orthopaedic Association Scores(one day before surgery, 3 months after surgery, 6 months after surgery)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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