The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The incidence of emergence delirium
研究概览
简要总结
Emergence delirium is a complex of perceptual deficits and psychomotor agitation most commonly seen in preschool children in the early post-anesthetic period. It increases the risk of bed falls, accidental catheter removal, surgical wound dehiscence, and delayed discharge in children. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to explore the effect of 40Hz stimulation on the incidence of emergence delirium in children undergoing vascular malformation surgery under sevoflurane anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized (like flipping a coin or drawing from a hat) to either of the two groups, with the probability of a participant being in the experimental and control groups being 1:1. and neither participant, nor care Provider, nor the outcome assessor, nor the investigator will know to which group participant has been assigned (or add 40 Hz transcranial stimulation).
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-14 years old
- •ASA classification I or II
- •Proposed vascular malformation surgery under sevoflurane general anesthesia
- •Anesthesia duration>1h
- •Obtaining informed consent
排除标准
- •Emergency surgery
- •Mental retardation
- •Neurological disorders with manic-like symptoms
- •Presence of severe kidney or liver disease, heart or respiratory disease
- •Autoimmune diseases
- •Vascular malformation of the head and face
- •Significant life changes in the 1 month prior to surgery
结局指标
主要结局
The incidence of emergence delirium
时间窗: From extubation to 2 h after extubation and day 1, day 2, day 3 after surgery.
Emergence delirium was considered to have occurred in the subject child if Pediatric Anesthesia Emergence Delirium (PAED) scale ≥10 or Cornell Assessment of Pediatric Delirium (CAPD) scale ≥10 (PAED range: 0-20 points, CAPD range: 0 \~ 32 points).
次要结局
- The incidence of pain(Day 1, day 2, day 3 after surgery.)
- Sleep quality(Day 1, day 2, day 3 after surgery.)
- The incidence of postoperative nausea and vomiting(Day 1, day 2, day 3 after surgery.)