Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
NCT ID:
NCT05525104
Group ID:
EG001
Title:
Treatment
Description:
In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend
Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children's hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children's hospital offers a diversity of diagrams including Density Spectral Array.
The electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
52
Other Number Affected:
0
Other Number At Risk:
52
Study:
NCT05525104
Results Section:
NCT05525104
Adverse Events Module:
NCT05525104