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临床试验/NCT05701748
NCT05701748已完成不适用

EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2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
100
试验地点
2
主要终点
EEG SEF95 value where 50% of infants do not respond to placement of oral pacifier

研究概览

简要总结

The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims to answer are:

  1. EEG spectral edge frequency (SEF) readings where 50% of patients do not respond to three stimuli.
  2. The propofol blood concentration that corresponds to each of the three EEG SEF readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.

详细描述

Sevoflurane inhalation and propofol intravenous anesthesia are the mainstays of delivering general anesthesia in children. Propofol anesthesia in children is gaining popularity due to fewer respiratory complications, less post-operative nausea vomiting and emergence delirium, compared to sevoflurane. However, unlike sevoflurane, the pharmacodynamics of propofol is less studied in infants and toddlers, particularly the biomarker for propofol brain effect site concentration (Ce), indicative of anesthetic depth. The lack of a real-time biomarker often results in over- or under-dosing of propofol in clinical practice. The goal of this study is to utilize electroencephalography (EEG) as the biomarker of propofol effect site concentration and clinical anesthetic depth, thereby improving the safety and efficacy of propofol anesthesia in this population. In infants and toddlers receiving propofol anesthesia, EEG will be recorded while the patient undergoes three stimuli used to assess anesthetic depth (placement of oral pacifier, electrical stimulation, and laryngoscopy). The EEG index (spectral edge frequency-SEF) where 50% of patients do not respond to each of the three stimuli will be determined as the biomarker of propofol clinical anesthetic depth.: In the same cohort, the regression between EEG SEF and plasma propofol levels will be determined to assess relationship between EEG SEF and propofol Ce.

研究设计

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

入排标准

年龄范围
3 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children 3 to 24 month old undergoing surgery.
  • Planned laryngoscopy and endotracheal intubation for clinical care.
  • Planned propofol anesthesia for anesthesia maintenance.
  • American Society of Anesthesiologists (ASA ) < III.
  • Muscle relaxant not indicated per planned clinical care for laryngoscopy/intubation.
  • Anticipated surgery duration approximately < 2h40min

排除标准

  • Patients undergoing emergency surgery.
  • Known severe neurological disease which might result in abnormal EEG SEF.
  • Deformities of forehead (difficult EEG sensor placement).
  • Known difficult airway.
  • Allergy to propofol.
  • Attending anesthesiologist on record caring for patient plans to administer additional IV medication besides propofol during study phase.
  • Currently on anti-seizure medication (might alter propofol pharmacodynamics).

结局指标

主要结局

EEG SEF95 value where 50% of infants do not respond to placement of oral pacifier

时间窗: Once SEF95 stabilizes at oral pacifier target SEF95 +/- 1Hz for at least one minute

Observation in OR and EEG data analysis

EEG SEF95 value where 50% of infants do not respond to electrical stimulation

时间窗: Once SEF95 stabilizes at electrical stimulation target SEF95 +/- 1Hz for at least one minute

Observation in OR and EEG data analysis

EEG SEF95 value where 50% of infants do not respond to laryngoscopy

时间窗: Once SEF95 stabilizes at laryngoscopy target SEF95 +/- 1Hz for at least one minute

Observation in OR and EEG data analysis

次要结局

  • Correlation of propofol blood concentration with EEG SEF95(Once SEF95 stabilizes for at least one minute)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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