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临床试验/NCT04362423
NCT04362423已完成不适用

A Pilot Study to Evaluate Functional Near Infrared Spectroscopy to Detect Pain in Infants and Young Children Under General Anesthesia

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
the changes of oxy-, deoxy-, total-hemoglobin

研究概览

简要总结

This is a three-phase pilot prospective study to develop a devise capable of detecting changes in cortical blood volume and oxygenation due to noxious stimuli. The hypothesis of the study is that optical signal changes corresponding to blood volume and oxygenation will be detected with functional near infrared spectroscopy in the prefrontal cortex of children under general anesthesia in response to peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP).

详细描述

Pain is a subjective feeling, and an objective measure of pain is needed to obtain improved clinical management and safe outcomes of pain treatment. At present, there is a lack of specific physiological markers of acute pain that can guide analgesic treatment both during and after surgery. The anesthesiologist typically relies on hemodynamic variables to guide administration of opioids for surgical pain, but those parameters are not always either specific or sensitive. On the other hand, uncontrolled pain during surgery can lead to emotional distress and enhancement of the systemic inflammatory response (1).

Current evidence (2-4) shows that the prefrontal cortex plays an important role in pain perception and emotional elaboration. Functional neuroimaging (functional magnetic resonance imaging functional magnetic resonance imaging (fMRI) functional near infrared spectroscopy fNIRS) has been recently utilized to investigate cerebral pain-related activity (5, 6).

The investigators propose to detect the optical signal changes over the prefrontal cortex using fNIRS and diffuse optical imaging (DOI) in response to noxious electrical stimulation. This electrical stimulation will be applied over the ulnar nerve at the wrist in children undergoing neurosurgery with SSEP monitoring. This noxious electrical stimulation is the standard stimulus used to establish baseline somatosensory evoked potentials in this patient population for this surgery. DOI is a mathematical methodology used to generate an image from the optical signals analogous to the mathematical methodology of generating a MRI from nuclear magnetic spectroscopy signals.

The investigators will evaluate the magnitude of change of fNIRS-DOI signals after two different intensities of noxious electrical stimulation and following intravenous administration of fentanyl (2 mcg/kg). The investigators will also analyze the temporal correlation of the prefrontal cortex fNIRS-DOI changes with the SSEPs. The results will lead to the identification of an objective specific biomarker for acute pain in children. Our long-term goal is to develop a portable and readily accessible device to improve management of intraoperative nociception and to evaluate acute pain in awake non-verbal children.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
1 Month 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •They are presenting for tethered spinal cord release , posterior fossa decompression, or spine surgery;
  • •They are between 1 month to 16 years of age;
  • •Their anesthetic plan includes endotracheal intubation and neuromonitoring;

排除标准

  • •Patients with a known history of chronic pain;
  • •Patients with abnormal frontal lobe brain structure or abnormality of forehead precluding the fNIRS probe securement;
  • •Patients with a known allergy to fentanyl;
  • •Patients with unstable hemodynamics.
  • •Patients with a contraindication to the use of propofol

结局指标

主要结局

the changes of oxy-, deoxy-, total-hemoglobin

时间窗: during stimulation (16 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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