跳至主要内容
临床试验/NCT06255236
NCT06255236已完成不适用

An Accuracy of Bispectral Index Monitoring in an Alternative Nasal Position Compared With Standard Frontal Position in Pediatric Patients Under General Anesthesia With Sevoflurane

Mahidol University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
bispectral index (BIS) value

研究概览

简要总结

To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia.

详细描述

Standard position of frontal bispectral index (BIS) may not be available in some operations that frontal area is occupied by surgical field. This prospective cohort study aims to compare the accuracy of the BIS between an alternative position across the nasal area with the standard frontal BIS position in pediatric patients undergoing general anesthesia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients undergoing general anesthesia
  • American Society of Anesthesiologists physical status 1-3

排除标准

  • Patients with neurological diseases
  • Patients who are using anticonvulsant drugs
  • Patients who is expected to be intubated and return to the pediatric intensive care unit
  • Patients undergoing head and face surgery
  • Patients undergoing surgery in the prone position
  • Patients who have contraindications to sevoflurane, thiopental, fentanyl, and cisatracurium

结局指标

主要结局

bispectral index (BIS) value

时间窗: 5 hours

BIS is a processed electroencephalogram (range from 0-100), the optimal value of BIS during general anesthesia is 40-60. We aim to define the differences between standard frontal BIS and nasal BIS using Bland-Altman analysis.

次要结局

  • signal quality index (SQI)(5 hours)
  • electromyography (EMG)(5 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验