Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
17 августа 2018 г. обновлено: 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.
Обзор исследования
Статус
Прекращено
Условия
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Действительный)
168
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Berlin, Германия, 13353
- Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - University Medicine Berlin
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 6 месяцев до 8 лет (Ребенок)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Вероятностная выборка
Исследуемая популяция
Children for elective surgery aged from 0, 5 to 8 years
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Incidence of emergence delirium and postoperative delirium
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Длительность пребывания в больнице
Временное ограничение: Участники будут находиться под наблюдением в течение всего периода пребывания в больнице, в среднем 7 дней.
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Участники будут находиться под наблюдением в течение всего периода пребывания в больнице, в среднем 7 дней.
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Тип операции
Временное ограничение: Во время операции
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Во время операции
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Depth of anesthesia
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: During the operation
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Measured by Narcotrend monitor
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During the operation
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Продолжительность операции
Временное ограничение: Во время операции
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Во время операции
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Time schedule for intraoperative EEG recording
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: During the operation
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During the operation
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Positive endexpiratory pressure
Временное ограничение: During the operation
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During the operation
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Inspiratory pressure
Временное ограничение: During the operation
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During the operation
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Tidal volume breathing frequency
Временное ограничение: During the operation
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During the operation
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Minute volume
Временное ограничение: During the operation
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During the operation
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Anxiety of the children
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Up to 5 postoperative days
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Up to 5 postoperative days
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Intensive care unit length of stay
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: During the operation
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During the operation
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Age
Временное ограничение: 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
Временное ограничение: At the beginning of the investigation
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At the beginning of the investigation
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Medical history
Временное ограничение: At the beginning of the investigation
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At the beginning of the investigation
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Previous number of surgeries
Временное ограничение: At the beginning of the investigation
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At the beginning of the investigation
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Previous medication
Временное ограничение: At the beginning of the investigation
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At the beginning of the investigation
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Main diagnosis
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
8 сентября 2015 г.
Первичное завершение (Действительный)
22 февраля 2017 г.
Завершение исследования (Действительный)
24 мая 2017 г.
Даты регистрации исследования
Первый отправленный
23 июня 2015 г.
Впервые представлено, что соответствует критериям контроля качества
24 июня 2015 г.
Первый опубликованный (Оценивать)
25 июня 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 августа 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 августа 2018 г.
Последняя проверка
1 августа 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- Narco-Kids
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Анестезия
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