跳至主要内容
临床试验/CTRI/2020/12/029871
CTRI/2020/12/029871尚未招募不适用

A feasibility study on the use of subdural somatosensory evoked potential monitoring during detethering surgery.

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1
主要终点
use of subdural ssep in detethering surgeries

研究概览

简要总结

In detethering surgery for tethered cord syndrome patients, damage to the neural structures is avoided by intraoperative monitoring of lower limb muscles, and perianal sphincter muscles by free running electromyography and, more rarely, with motor evoked potentials. However the sensory nerves or the sensory part of the neural placode containing the conus medullaris are not monitored and could be damaged during the surgical procedure. Sensory evoked potential monitoring of the perianal region and the lower limbs were not considered useful during detethering surgery though technically possible. Recently there has been a report of a novel method monitoring the SSEP directly over the spinal cord and we would like to replicate the study in our setting and measure the amplitude and latency during the procedure.

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Patients with tethered cord syndrome, which can involve cases with myelomeningocele, lipomyelomeningocele, and lumbosacral split cord malformations, and these operations are usually done in children but can rarely be done in adults also.
  • So the age group involved is generally below 12 years but can be done in any age group if the patients present late.

排除标准

  • Patients with preexisting severe sensory loss with large pressure sores where the possibility of obtaining an SSEP is unlikely.

结局指标

主要结局

use of subdural ssep in detethering surgeries

时间窗: recording the sensory potential directly from the spinal cord during the time to surgery

次要结局

  • Feasibility of the Somatosensory evoked potential during detethering surgery(During the time of detethering surgery)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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