跳至主要内容
临床试验/CTRI/2012/07/002788
CTRI/2012/07/002788已完成不适用

Heart rate variability as a tool to assess autonomic nervous system in patients with neurosurgical disorders.

National Institute Of mental Health and Neuro Sciences1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2012年1月9日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
•Heart rate variability measured in terms of time domain, frequency domain and non linear model

研究概览

简要总结

Autonomic nervous system reflexly controls the vital functions of the human body and is controlled by the higher centers in the brain. Lesions in these pathways can result in increased morbidity and mortality of these patients undergoing surgery under anesthesia. Assessment of this system by means of heart rate variability will provide insight into the functioning of the autonomic nervous system and can be used to optimize patient care. Adult patients undergoing surgery for cervical myelopathy, supratentorial and infratentorial tumors, and subarachnoid hemorrhage will be recruited for the project. Five minute recordings of ECG will be done either before or on the day of surgery using surface electrodes. R-R interval will be calculated using proprietary software. With this data, both linear and non models would be used to derive various parameters of heart rate variability. This would be correlated with intraoperative hemodynamic instability and condition of patients at discharge.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Males or females ≥ 18 years Patients requiring surgery for Cervical spine pathologies, Posterior fossa and supratentorial tumors, Hydrocephalus, Craniopharyngiomas, subarachnoid hemorrhage.
  • Patients undergoing lumbar spine surgeries (reference group).

排除标准

  • •Patients having cardiac pacemaker, abnormal rhythms •Patients on beta blocker therapy.

结局指标

主要结局

•Heart rate variability measured in terms of time domain, frequency domain and non linear model

时间窗: •24 hours prior to surgery

次要结局

  • •Incidence of heart rate changes (±20%) and blood pressure changes (±20%).

研究者

申办方类型
Research institution and hospital

研究点 (1)

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