Effect of Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Emergence time
研究概览
简要总结
Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2 and 8 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive an operation under general anesthesia
排除标准
- •ASA PS III or IV
- •with developmental delay or neurological diseases associated with symptoms of agitation
- •refusal of consent
- •with developmental delay
- •with allergy or contraindication to use of ketamine (presence of an active upper respiratory tract infection (URI), increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)
研究组 & 干预措施
stranger's voice
At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.
干预措施: recorded stranger's voice (Procedure)
maternal voice
At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation.
干预措施: recorded maternal voice (Procedure)
结局指标
主要结局
Emergence time
时间窗: During 1 hour after operation
time from discontinuation of anesthetics to extubation
Incidence of emergence delirium (ED)
时间窗: During 30 minutes after PACU admission
The incidence of emergence delirium (ED) was defined as pediatric anesthesia emergence delirium (PAED) score of \>12 or Watcha scale over 3.
次要结局
- BIS over 60(During 1 hour after operation)
- peak Watcha scale(During 30 minutes after PACU admission)
- eye opening or purposeful movement time(During 1 hour after operation)
- peak PAED scale(During 30 minutes after PACU admission)
研究者
Eugene Kim
Assistant professor
Daegu Catholic University Medical Center