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临床试验/NCT04190082
NCT04190082终止不适用

The Effect of Bispectral Index Monitoring on the Speed of Recovery From Deep Propofol Sedation in Children With Cerebral Palsy - A Randomized Controlled Trial

Yeungnam University College of Medicine1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
recovery

研究概览

简要总结

The purpose of this study was to compare BIS (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection.

详细描述

After arrival in the preoperative holding area, children were randomly allocated into two groups using a computer-generated random assignment scheme. Five minutes before propofol sedation, remifentanil is administered intravenously at 0.025 μg / kg / min for analgesic effect and continued throughout the sedation process until just before the end of the procedure. Five minutes after remifentanil administration, 2 mg / kg of propofol mixed with 1 mg / kg of lidocaine was administered over 30 seconds, followed by continuous infusion at 100 μg / kg / min. Group C is monitored using UMSS(University of Michigan Sedation Scale) scores every three minutes, and group B is monitored using BIS score until deep sedation. Deep sedation is defined based on UMSS score of 3-4 and BIS score of 65 ± 5. If the sedation score is determined to have reached a deep sedation, a botulinum toxin injection is given by a practitioner blind to how to assess the depth of sedation. Independent investigator who is blind to group assignement assesses the oxygen saturation, respiration, and blood pressure, recovery time from sedation, and adverse events during and after sedation.

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
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 3-12 years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation
  • American Society of Anesthesiologists Physical Status 1-2

排除标准

  • Body mass index > 30 kg/m2
  • unstable heart disease
  • Anticipated difficult airway including congenital facial or airway anomaly
  • Recent upper respiratory tract infection ( < 2 weeks)
  • Gastroesophageal reflux
  • Allergy history to propofol, remifentanil or any drug used during procedure

结局指标

主要结局

recovery

时间窗: Immediately after discontinuation of propofol infusion used for botulinum toxin injection

Time taken to recover based on the Physiological CBD score (\>12) from deep sedation

次要结局

  • Propofol dose(Immediately after discontinuation of propofol infusion used for botulinum toxin injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Mee Jung

Professor

Yeungnam University College of Medicine

研究点 (1)

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