Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- initial PAED score
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
- Quadruple (Participant, Care Provider, Investigator, 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 ophthalmology or otorhinolaryngology surgery 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
- •maternal mutism
- •absence of mother
- •with allergy or contraindication to use of ketamine (increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)
研究组 & 干预措施
Group M
At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation.
干预措施: recorded maternal voice (Procedure)
Group S
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)
结局指标
主要结局
initial PAED score
时间窗: During 1 minutes after PACU admission
On arrival at post-anesthesia care unit (PACU), patients were checked PAED. The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.
次要结局
- BIS over 60(During 1 hour after operation)
- Incidence of emergence delirium (ED)(During 60 minutes after PACU admission)
- PAED score on 10, 20, and 30 min(During 60 minutes after PACU admission)
- Watcha scale on initial, 10, 20, and 30 min(During 60 minutes after PACU admission)
- BIS over 70 and 80 time(During 1 hour after operation)
- FLACC score on initial, 10, 20, and 30 min(During 60 minutes after PACU admission)
- Extubation time(During 1 hour after operation)
- mean blood pressure(During 1 hour after operation)
- Heart rate(During 1 hour after operation)
- Eye opening or purposeful movement time(During 1 hour after operation)
研究者
Eugene Kim
Assistant professor
Daegu Catholic University Medical Center