Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 8 |
| Updated: | 10/28/2017 |
| Start Date: | September 8, 2015 |
| End Date: | December 2019 |
| Contact: | Claudia Spies, MD, Prof. |
| Email: | claudia.spies@charite.de |
| Phone: | +49 30 450 450 551001 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Boston, Massachusetts 02115
Principal Investigator: Keira Mason, MD, Prof.
Phone: 617-355-7737
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Berlin, 13353
Principal Investigator: Claudia Spies, MD, Prof.
Phone: +49 30 450 55 10 01
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