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


- candidate number24458
- NTR NumberNTR5890
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jun-2016
- Secondary IDsNL56591.078.16 
- Public TitleEndoscopy with EEG-control in children between 1 and 12 years
- Scientific TitleThe influence of electroencephalographic Narcotrend Index™ - guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in children between 1 and 12 years
- ACRONYMNI-PPS 2
- hypothesisNarcotrend Index (Depth of Hypnosis Index, derrived from EEG) guided application of propofol may result in faster emergence after procedural sedation for gastrointestinal endoscopy in paediatric patients aged between 1 and 12 years
- Healt Condition(s) or Problem(s) studiedSedation, Children, Propofol, EEG, Endoscopy
- Inclusion criteriaWritten informed consent of patients and their parents/legal representatives
Age ≥1 and <12 years
Bodyweight >5 and ≥60 kg (limitation of the paediatric pharmocokinetic model)
Gastrointestinal endoscopy
Eligibility for procedural sedation
Ability of the patient to communicate in Dutch
- Exclusion criteriaPrimary exclusion criteria:
Withdrawal of informed consent
Chronic exposure (more than one day) to psychotropic drugs and/or opioids
Known allergy/intolerance for propofol and/or remifentanil
Anticipated difficult airway
Child not eligible for procedural sedation, need for general anaesthesia
Patient and/or parents unable to communicate in Dutch

Secondary exclusion criteria:
Unexpected procedural events requiring endotracheal intubation
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-jun-2016
- planned closingdate31-dec-2017
- Target number of participants40
- InterventionsPatients are prospectively randomised to two groups. In the intervention group the application of propofol to provide procedural sedation for gastrointestinal endoscopy is guided by the Narcotrend Index of hypnotic depth. In the control group dosing of propofol is based on clinical observations of depth of hypnosis.
- Primary outcomeThe 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 outcomeCumulative anaesthetic drug consumption
Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthesia care unit. Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend
Incidence of recall of events during the procedure (awareness)
Assessment of endoscopy conditions (by paediatric gastroenterologist)
Adverse events
- TimepointsDataanalysis after completion of inclusion
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. F. Weber
- CONTACT for SCIENTIFIC QUERIESDr. F. Weber
- Sponsor/Initiator Erasmus Medical Centre, Sophia Childrens Hospital, Department of Anaesthesia
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Childrens Hospital, Department of Anaesthesia
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-jun-2016 - 8-jul-2016


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