Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium and postoperative delirium
研究概览
简要总结
Evaluation of mechanisms and factors of anaesthesia on postoperative delirium and emergence agitation as well as on postoperative cognitive function in children aged 0,5-8 years scheduled for elective surgery. The depth of anesthesia in children for elective surgery aged 0,5-6 years is monitored with intraoperative "Narcotrend-Compact-M-Monitoring". Postoperatively the "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" [Sikich et al. 2004;Locatelli et al. 2013] is used to screen for the frequency of postoperative delirium in the post anesthesia care unit discharge of the child after surgery. Cognitive testings are performed in children of the study group (n= 470) and a control group (n= 80) with the parents support to evaluate deficits in children in their cognitive areas (POCD (Postoperative cognitive deficit)) at three different time points up to three months.
详细描述
According to recent studies in children aged from 0,5 to 8 years "Narcotrend Monitor" (from EEG derived monitoring of the frontal brain waves) can reliably measure the depth of anesthesia [Münte et al. 2009; Weber et al. 2005].
Depth of anesthesia in adults is significantly correlated with the incidence of postoperative delirium and longer lasting cognitive deficits [Radtke et al. 2013; Chan et al. 2013; Whitlock et al. 2014].
We know from animal experimental studies that anesthetics have a potential toxic effect in the developing brain. [Sinner et al 2014].
After two years (approximately 1/3 - 1/2 of the total sample) an interim analysis with recalculation of the case numbers is carried out, if the initial effect sizes differ strongly.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female children 0,5 to 8 years
- •planned elective surgery
- •informed consent by both parents, if both parents have joint custody
排除标准
- •indication for isolation of patients with multi-resistant bacteria
- •known neurological or psychiatric precondition (disease)
- •inability of the parents to speak and or read German
- •lacking willingness to save and hand out pseudonomized data within the clinical study
- •contact allergy to silver or silver chloride
- •participation in another prospective interventional clinical study during this study
- •Control Group:
- •Inclusion Criteria:
- •male or female healthy children 0,5 to 8 years (siblings of study group and children from kindergarten)
- •no planned operation in the next three month
- •no operation in the last half year before study inclusion
- •informed consent by both parents, if both parents have joint custody
- •Exclusion Criteria:
- •Neurological or psychiatric precondition (disease), which limits the conduction of the neurocognitive testing
- •Anacusis or Hypoacusis, which limits the conduction of the neurocognitive testing
- •Taking psychotropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis and substances, which limit the conduction of the neurocognitive testing
- •Inability of the parents to speak and or read the used language
- •Lacking willingness to save and hand out pseudonomized data within the clinical study
结局指标
主要结局
Incidence of emergence delirium and postoperative delirium
时间窗: Until discharge of the child from the recovery room, an expected average of 1 hour
The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)
次要结局
- Body temperature(During the operation)
- Stress reducing agents(Up to the end of stay in the recovery room, an expected average of 1 hour)
- Depth of anesthesia(During the operation)
- Duration of emergence Delirium(Until discharge of the child from the recovery room, an expected average of 1 hour)
- Type of surgery(During the operation)
- Psychoactive drugs/Benzodiazepines(From 1h before surgery start up to the end of stay in the operation (an expected average of 2 hours))
- Fluid and transfusion therapy(From one day before surgery start up to the end of stay in the recovery room (an expected average of 2 hours)
- Incidence of behavioral problem(Up to 5 postoperative days)
- Severity of emergence Delirium(Until discharge of the child from the recovery room, an expected average of 1 hour)
- Hemoglobin(Up to 5 postoperative days)
- Carbon dioxide (CO2) and oxygen (O2) monitoring(During the operation)
- Compliance of the children(At the beginning of the operation)
- Clinical routine anesthesia parameters(Up to the end of stay in the recovery room, an expected average of 1 hour)
- Blood gas analysis(Up to the end of stay in the recovery room, an expected average of 1 hour)
- Specific field of surgery(During the operation)
- Lactate(Up to 5 postoperative days)
- Glucose(Up to 5 postoperative days)
- Soluble Interleukin - 6(Up to the end of the operation)
- Hypnotics(Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour)
- Burst suppression ratio(During the operation)
- Duration of surgery(During the operation)
- Time schedule for intraoperative EEG recording(During the operation)
- C-reactive protein(Up to 5 postoperative days)
- Positive endexpiratory pressure(During the operation)
- Tidal volume breathing frequency(During the operation)
- Analgesia(Up to the end of stay in the recovery room, an expected average of 1 hour)
- Postoperative cognitive deficit (POCD) in children 6 to 42 months(Up to 365 postoperative days)
- Postoperative cognitive deficit (POCD) in children 43 to 96 months(Up to 365 postoperative days)
- Duration of anesthesia(During the operation)
- Pain in children ≥ 4 years(Up to the end of stay in the recovery room, an expected average of 1 hour)
- Stress(Up to 365 postoperative days)
- Pain in children < 4 years(Up to the end of stay in the recovery room, an expected average of 1 hour)
- Inspiratory pressure(During the operation)
- Anxiety of the parents(Up to 365 postoperative days)
- Intensive care unit length of stay(Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day)
- Hospital length of stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Behavioral changes of the children(Up to 5 postoperative days)
- Minute volume(During the operation)
- Anxiety of the children(Up to 365 postoperative days)
- Postoperative organ complications(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Anxiety of children(At the beginning of the operation)
- Blood pressure(During the operation)
- Incidence of Delirium(Up to the end of stay in the recovery room, an expected average of 1 hour)
- Heart rate(During the operation)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK)
Charite University, Berlin, Germany