Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
2018年8月17日 更新者：Claudia Spies、Charite University, Berlin, Germany
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.
研究概览
地位
终止
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
168
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Berlin、德国、13353
- Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 8年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Children for elective surgery aged from 0, 5 to 8 years
描述
Study Group.
Inclusion Criteria:
- male or female children 0,5 to 8 years
- planned elective surgery
- informed consent by both parents, if both parents have joint custody
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Study group: Patients
470 children for elective surgery 0,5 to 8 years Analysis of EEG data will divided in four age-related groups because of the different baseline EEG activity:
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Control group: Healthy children for POCD assessment
80 healthy children (siblings of study group children and children from Kindergarten) 0,5 to 8 years with no operation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Incidence of emergence delirium and postoperative delirium
大体时间：Until discharge of the child from the recovery room, an expected average of 1 hour
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The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)
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Until discharge of the child from the recovery room, an expected average of 1 hour
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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住院时间
大体时间：参与者将在住院期间接受随访，预计平均 7 天
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参与者将在住院期间接受随访，预计平均 7 天
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手术类型
大体时间：手术过程中
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手术过程中
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Depth of anesthesia
大体时间：During the operation
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Depth of anesthesia assessed by band-power of the 4 frequency bands (alpha, beta, theta, delta) and activity in percentages of total spectral power ( F50% / F95%) assessed with Narcotrend Monitor
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During the operation
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Incidence of behavioral problem
大体时间：Up to 5 postoperative days
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The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire" (PHBQ) (Buehrer et al. 2014)
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Up to 5 postoperative days
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Severity of emergence Delirium
大体时间：Until discharge of the child from the recovery room, an expected average of 1 hour
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The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004; Locatelli et al. 2013)
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Until discharge of the child from the recovery room, an expected average of 1 hour
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Duration of emergence Delirium
大体时间：Until discharge of the child from the recovery room, an expected average of 1 hour
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The Delirium is measured by Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" [Sikich et al. 2004; Locatelli et al. 2013]
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Until discharge of the child from the recovery room, an expected average of 1 hour
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Lactate
大体时间：Up to 5 postoperative days
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Laboratory parameter
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Up to 5 postoperative days
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Hemoglobin
大体时间：Up to 5 postoperative days
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Laboratory parameter
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Up to 5 postoperative days
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Soluble Interleukin - 6
大体时间：Up to the end of the operation
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Laboratory parameter
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Up to the end of the operation
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Analgesia
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Up to the end of stay in the recovery room, an expected average of 1 hour
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Hypnotics
大体时间：Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour
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Begin of Anesthesia up to the end of stay in the recovery room, an expected average of 1 hour
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Stress reducing agents
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Up to the end of stay in the recovery room, an expected average of 1 hour
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Psychoactive drugs/Benzodiazepines
大体时间：From 1h before surgery start up to the end of stay in the operation (an expected average of 2 hours)
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From 1h before surgery start up to the end of stay in the operation (an expected average of 2 hours)
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Fluid and transfusion therapy
大体时间：From one day before surgery start up to the end of stay in the recovery room (an expected average of 2 hours
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The fluid and transfusion therapy is measured by preoperative sobriety times by intraoperative fluid and volume administration and balance.
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From one day before surgery start up to the end of stay in the recovery room (an expected average of 2 hours
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Postoperative cognitive deficit (POCD) in children 6 to 42 months
大体时间：Up to 365 postoperative days
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POCD is measured by parent questionnaires (BRIEF-P) and in children by the Bayley III Scales of Infant and Toddler Development (cognitive, language, motor function and processing speed, social emotional scale) and NEPSY II (Statue, word generation, Visuomotor precision from 3 years).
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Up to 365 postoperative days
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Postoperative cognitive deficit (POCD) in children 43 to 96 months
大体时间：Up to 365 postoperative days
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POCD is measured by parent questionnaires (BRIEF-P, BRIEF) and in children by the Colored Progressive Matrices (CPM), the CANTAB test battery and NEPSY-II subtests (Visuomotor precision, word generation, statue (until 6 years); animal sorting (from 7 years)).
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Up to 365 postoperative days
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Duration of anesthesia
大体时间：During the operation
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Measured by Narcotrend monitor
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During the operation
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Burst suppression ratio
大体时间：During the operation
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Measured by Narcotrend monitor
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During the operation
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手术持续时间
大体时间：手术过程中
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手术过程中
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Time schedule for intraoperative EEG recording
大体时间：During the operation
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Predefined time points: Baseline, start of anesthetic administration (STARTAnesth), start of analgesic administration (STARTAnalg), Loss of consciousness (LOC), airway device insertion [INT], skin incision/ surgery start (SKIN), intraoperative steady state (OP), stop of anesthetic administration (ENDAnesth), stop of analgesic administration (ENDAnalg),airway device removal [EXE] regain of consciousness (ROC), awakening (AWK)
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During the operation
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Pain in children < 4 years
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Pain is measured by the FLACC- Scale
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Up to the end of stay in the recovery room, an expected average of 1 hour
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Pain in children < 4 years
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Pain is measured by the KUSS-Score
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Up to the end of stay in the recovery room, an expected average of 1 hour
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Pain in children ≥ 4 years
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Pain is measured by the Faces Pain Scale - revised
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Up to the end of stay in the recovery room, an expected average of 1 hour
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C-reactive protein
大体时间：Up to 5 postoperative days
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Up to 5 postoperative days
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Carbon dioxide (CO2) and oxygen (O2) monitoring
大体时间：During the operation
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During the operation
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Positive endexpiratory pressure
大体时间：During the operation
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During the operation
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Inspiratory pressure
大体时间：During the operation
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During the operation
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Tidal volume breathing frequency
大体时间：During the operation
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During the operation
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Minute volume
大体时间：During the operation
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During the operation
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Anxiety of the children
大体时间：Up to 365 postoperative days
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Observation of anxiety during psychological assessment on a 4-point-Likert-scale
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Up to 365 postoperative days
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Anxiety of the parents
大体时间：Up to 365 postoperative days
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Baseline (STAI) after 3 months (STAI)
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Up to 365 postoperative days
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Compliance of the children
大体时间：At the beginning of the operation
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Measured by Induction compliance checklist
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At the beginning of the operation
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Stress
大体时间：Up to 365 postoperative days
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Stress is measured of of parents and of children.
Parenting stress index (PSI) (German version: Eltern-Belastungsinventar (EBI))
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Up to 365 postoperative days
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Glucose
大体时间：Up to 5 postoperative days
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Up to 5 postoperative days
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Intensive care unit length of stay
大体时间：Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
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Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
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Postoperative organ complications
大体时间：Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Behavioral changes of the children
大体时间：Up to 5 postoperative days
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Post Hospitalization Behavior Questionnaire (PHBQ)
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Up to 5 postoperative days
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Anxiety of children
大体时间：At the beginning of the operation
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mYale-SF (2-8 years)
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At the beginning of the operation
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Blood pressure
大体时间：During the operation
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This Monitoring of the blood pressure will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
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During the operation
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Body temperature
大体时间：During the operation
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This Monitoring of body temperature will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
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During the operation
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Heart rate
大体时间：During the operation
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This Monitoring of heart rate will be measured at the defined EEG measurement timepoints from STARTAnesth to EXE.
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During the operation
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Clinical routine anesthesia parameters
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Clinical routine anesthesia parameters are measured by primary induction technique, type of induction, type of maintenance of anesthesia, airway management, additional regional anesthesia, type of regional anesthesia, time of regional anesthesia, application during operation and blood gas analysis) during anesthesia until end of recovery room stay.
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Up to the end of stay in the recovery room, an expected average of 1 hour
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Blood gas analysis
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Up to the end of stay in the recovery room, an expected average of 1 hour
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Incidence of Delirium
大体时间：Up to the end of stay in the recovery room, an expected average of 1 hour
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Incidence of Delirium is measured with the CAPD-Score [Dill et al. 2016]
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Up to the end of stay in the recovery room, an expected average of 1 hour
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Specific field of surgery
大体时间：During the operation
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During the operation
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Age
大体时间：At the beginning of the investigation
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Age will be measured in months and in years
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At the beginning of the investigation
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ASA classification
大体时间：At the beginning of the investigation
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At the beginning of the investigation
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Medical history
大体时间：At the beginning of the investigation
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At the beginning of the investigation
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Previous number of surgeries
大体时间：At the beginning of the investigation
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At the beginning of the investigation
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Previous medication
大体时间：At the beginning of the investigation
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At the beginning of the investigation
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Main diagnosis
大体时间：At the beginning of the investigation
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he diagnosis that is responsible for occasioning the performance of inpatient treatment.
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At the beginning of the investigation
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Demographic and background data
大体时间：At the beginning of the investigation
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Demographic and background data are collected by gender, ethnicity, education of the parents, language, number of siblings, family Situation)
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At the beginning of the investigation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Koch S, Stegherr AM, Rupp L, Kruppa J, Prager C, Kramer S, Fahlenkamp A, Spies C. Emergence delirium in children is not related to intraoperative burst suppression - prospective, observational electrography study. BMC Anesthesiol. 2019 Aug 8;19(1):146. doi: 10.1186/s12871-019-0819-2.
- Koch S, Rupp L, Prager C, Wernecke KD, Kramer S, Fahlenkamp A, Spies CD. Emergence delirium in children is related to epileptiform discharges during anaesthesia induction: An observational study. Eur J Anaesthesiol. 2018 Dec;35(12):929-936. doi: 10.1097/EJA.0000000000000867.
- Koch S, Rupp L, Prager C, Morgeli R, Kramer S, Wernecke KD, Fahlenkamp A, Spies C. Incidence of epileptiform discharges in children during induction of anaesthesia using Propofol versus Sevoflurane. Clin Neurophysiol. 2018 Aug;129(8):1642-1648. doi: 10.1016/j.clinph.2018.05.013. Epub 2018 Jun 8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年9月8日
初级完成 (实际的)
2017年2月22日
研究完成 (实际的)
2017年5月24日
研究注册日期
首次提交
2015年6月23日
首先提交符合 QC 标准的
2015年6月24日
首次发布 (估计)
2015年6月25日
研究记录更新
最后更新发布 (实际的)
2018年8月20日
上次提交的符合 QC 标准的更新
2018年8月17日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- Narco-Kids
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