Endoscopy with EEG-contol
Completed
- Conditions
- SedationPropofolChildrenGastrointestinal endoscopyDepth of Anaesthesia MonitoringEEG
- Registration Number
- NL-OMON28327
- Lead Sponsor
- Erasmus University Medical CenterSophia Children's HospitalRotterdamThe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Written informed consent of patients and their parents/legal representatives
Age ¡Ý12 and <17 years
Exclusion Criteria
Primary exclusion criteria:
Withdrawal of informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Cumulative anaesthetic drug consumption<br /><br>Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthesia care unit. <br /><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 /><br>Economic Analysis (Cost minimization analysis, CMA)<br>