Emergence Agitation in Paediatric Day Care Surgery: A Randomised, Single-blinded Study Comparing Narcotrend and Heart Rate Variability With Standard Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Richmond Agitation Sedation Scale Score
研究概览
简要总结
Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age.
In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS).
93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.
详细描述
Healthy preschool outpatients assigned for abdominal/inguinal hernia and cryptorchidism repairs participated after parental consent.
One group received standard anaesthesia induction and maintenance, according to the usual ward regimen. This was done with sevoflurane inhalation, fentanyl bolus and a laryngeal mask airway (Standard group, STD group)
The second group received standard anaesthesia as well only this time the sevoflurane titration was guided via the Nacotrend bispectral index monitor, towards a narcotrend index of 2-4. (Narcotrend group, NCT group)
The third group also received standard anaesthesia and was additionally monitored with a Mdoloris Anaesthesia Nociception Index (ANI) monitor for perioperative nociception. When a nociceptive threshold was exceeded, an extra bolus of fentanyl of 1 mcg/kg was given (ANI group)
All children were then escorted to the postoperative care unit for wakeup. A Richmond Agitation Sedation Scale score (RASS-score) was made every 15 minutes until discharge. This was analysed with Kaplan-Meyer mortality graph, along with usual statistics of secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Day surgery for abdominal and urological procedures
- •Children 1-6 years
- •American Society of Anesthesiologist (ASA) scale 1- 2
- •Airway management with laryngeal masks or facemasks
- •Consent from both parents/legal representatives
- •Rescue propofol is allowed
排除标准
- •Age less than 1 or older than 6 years
- •Endotracheal intubation;
- •Lack of consent from both parents/legal representatives
- •Daily intake of medications that interfered with the autonomic nervous system reactivity, for example, inhaled beta-agonists for bronchial asthma and total intravenous anaesthesia (TIVA).
结局指标
主要结局
Richmond Agitation Sedation Scale Score
时间窗: During postoperative care unit (PACU) stay within 0-8 hours
Scoring system for sedation and agitation from -5 til +4.
次要结局
- Fentanyl consumption(Within 48 hours of hospital admission)
- Nurse-VAS(Within the duration of PACU stay of 0-8 hours)
- Other medications(During the first 24 postoperative hours)
- PONV(Within the duration of PACU stay of 0-8 hours)
- Time consumption(Within 48 hours of hospital admission)