Electroencephalogram Study in Children Under Remimazolam Anesthesia - a Prospective,Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time-frequency characteristics of electroencephalogram (EEG)
研究概览
简要总结
The effect of Remimazolam on brain electrical activity. Previous studies have shown that in healthy male volunteers, EEG changes during Remimazolam infusion are characterized by an initial increase in the beta band and a later increase in the delta band. When monitoring the depth of anesthesia, the commonly used Bispectral Index in clinical practice was originally developed for propofol. Therefore, studies have shown that the correlation between the depth of sedation of benzodiazepines such as midazolam and Bispectral Index is weak. In contrast, the beta wave ratio is considered a more suitable EEG indicator for monitoring the sedative effect of Remimazolam. The above indicates that Remimazolam has a specific pattern of influence on EEG activity, especially in the regulation of anesthesia depth, with unique characteristics.
详细描述
This study is a prospective, observational study.Children undergoing elective general anesthesia with Remimazolam will be divided into three groups (1-3 years old, 4-6 years old, 7-12 years old) based on their age range, with 20 cases in each group.Inform the family of the general research plan and obtain informed consent. Main outcome measure: Time frequency characteristics of electroencephalography (EEG) in children of different age groups under general anesthesia withRemimazolam (including anesthesia induction, maintenance, and recovery periods).
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 1 years-12 years; 2, with American Society of Anesthesiologists (ASA) physical status I or II; 3, children requiring general anesthesia under remimazolam; 4, parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.
排除标准
- •Congenital malformation or other genetic conditions that are thought to affect brain development ;
- •History of severe heart, brain, liver, kidney and metabolic diseases ;
- •Premature infants (≤32 weeks);
- •Upper respiratory tract infection in the last two weeks. -
结局指标
主要结局
Time-frequency characteristics of electroencephalogram (EEG)
时间窗: Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)
Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery) .
次要结局
- Modified observer's assessment of alertness/sedation (MOAA/S)(Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery))
- Recovery time(Within up to 30 minutes after operation)
- Pediatric anesthesia emergence delirium(Within up to 30 minutes after operation)
- The Face, Legs, Activity, Cry, Consolability Scale (FLACC)(Within up to 30 minutes after operation)