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Endoscopy with EEG-control in children between 1 and 12 years

Recruiting
Conditions
Sedation, Propofol, Children, Endoscopy, EEG
Registration Number
NL-OMON23511
Lead Sponsor
Erasmus University Medical Center, Sophia Children's Hospital, Department of AnaesthesiaRotterdam, The Netherlands
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

Written informed consent of patients and their parents/legal representatives

Age ≥1 and <12 years

Exclusion Criteria

Primary exclusion criteria:

Withdrawal of informed consent

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary objective of this study is the effect of electroencephalographic Narcotrend Index (NI) monitoring on the speed of recovery from Procedural Sedation for paediatric gastrointestinal endoscopy.
Secondary Outcome Measures
NameTimeMethod
Cumulative anaesthetic drug consumption<br /><br>Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthesia care unit. <br>Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend<br /><br>Incidence of recall of events during the procedure (awareness)<br /><br>Assessment of endoscopy conditions (by paediatric gastroenterologist)<br /><br>Adverse events<br />
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