Comparison of the Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children: a Prospective Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Presence of ED (in EEG and BIS groups) - PAED scale
研究概览
简要总结
The aim of the study is to compare two modalities of measuring the depth of general anaesthesia on the incidence of emergent delirium in children.
详细描述
Preoperative preparation and the method of administering general anaesthesia will be conducted based on a standardised protocol. Each patient included in the study will be administered sedative premedication Midazolam at a dose of 0.5mg/kg per os 45-60 minutes before the operation. During transfer to the operating room, Parental Separation Anxiety Scale (PSAS) and Modified Yale Preoperative Anxiety Scale (m-YPAS) will be evaluated to assess the level of preoperative anxiety as a risk factor for emergent delirium (ED). Inhalation induction of general anaesthesia with a flow rate of 4l/min O2:air with Fio2 0.5 to achieve sufficient depth of general anaesthesia, followed by provision of peripheral venous catheter, administration of Sufentanil at a dose of 0.2uq/kg and Paracetamol 15mg/kg. Airways will be secured preferentially by a laryngeal mask, in case of leakage or the nature of the procedure by orotracheal intubation. After ensuring the airways, the gas flow is reduced to 2.5%. Immediately in the electroencephalography (EEG) group, a trained nurse connects the EEG and initiates monitoring with titration of Sevoflurane to achieve a sufficient depth of unconsciousness, which will be assessed by an EEG specialist.
In the Bispectral Index (BIS) group, the child will be equipped with a BIS electrode and the depth of general anaesthesia will be controlled with the aim of BIS values of 40-60.
The time from the start of the connection to the start of the measurement of the depth of anaesthesia, the total duration of the operation and anaesthesia will also be recorded.
During anaesthesia, in addition to vital functions, the concentration of the anaesthetic and its consumption, signs of insufficient depth of general anaesthesia will be recorded In the recovery room, scales to determine the presence of emergent delirium will be assessed - Paediatric Anesthesia Emergence Delirium scale (PAED) and Watcha scale, as well as Face, Legs, Activity, Cry, Consolability scale (FLACC) and other parameters.
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
盲法说明
No masking will be used in the study.
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
- •Patient aged 1-6 years indicated for surgery (hernioplasty, orchidopexy)
- •Consent of parents/legal guardians
- •Health status corresponding to ASA (American Society of Anesthesiologists) I and II
排除标准
- •Disagreement of parents/legal guardians with inclusion in the study
- •Neurological disease, severe hearing and vision impairment
- •Health status corresponding to ASA (American Society of Anesthesiologists) III and above
研究组 & 干预措施
EEG monitoring
Study subjects randomised into this arm will undergo EEG monitoring during anaesthesia.
干预措施: EEG monitoring (Diagnostic Test)
BIS monitoring
Study subjects randomised into this arm will undergo BIS monitoring during anaesthesia.
干预措施: BIS monitoring (Diagnostic Test)
结局指标
主要结局
Presence of ED (in EEG and BIS groups) - PAED scale
时间窗: 2 hours after surgery
The presence of emergence delirium in the EEG and BIS groups will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale at the recovery room. The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a 5-item, validated observational tool used to measure the severity of delirium in children during anesthesia recovery, with scores \>10-12 indicating significant emergence delirium (ED).
Presence of ED (in EEG and BIS groups) - Watcha scale
时间窗: 2 hours after surgery
The presence of emergence delirium in the EEG and BIS groups will be assessed using the Watcha scale at the recovery room. The Watcha scale is a simple 4-point observational tool used to assess pediatric emergence delirium (ED) (agitation or confusion) as children wake up from general anesthesia. It measures the severity of agitation, with scores \>2 generally indicating significant agitation or delirium.
Presence of ED (in EEG and BIS groups) - FLACC scale
时间窗: 2 hours after surgery
The presence of emergence delirium in the EEG and BIS groups will be assessed using the FLACC scale at the recovery room. The FLACC scale (Face, Legs, Activity, Cry, Consolability) is a behavioral tool designed to measure pain in infants, young children (2 months to 7 years), and non-verbal patients. It evaluates five behaviors, scoring each from 0-2, for a total score of 0-10, where higher scores indicate greater pain.
次要结局
- Safety of EEG and BIS monitoring in relation to ED - heart rate(During general anaesthesia, up to 2 hours)
- Safety of EEG and BIS monitoring in relation to ED - blood pressure(During general anaesthesia, up to 2 hours)
- Safety of EEG and BIS monitoring in relation to ED - patient movement(During general anaesthesia, up to 2 hours)
- Safety of EEG and BIS monitoring in relation to ED - patient sweating(During general anaesthesia, up to 2 hours)
- Safety of EEG and BIS monitoring in relation to ED - patient lacrimation(During general anaesthesia, up to 2 hours)