No registrations found.
ID
Source
Brief title
Health condition
Sedation
Propofol
Children
Gastrointestinal endoscopy
Depth of Anaesthesia Monitoring
EEG
Sponsors and support
Sophia Children's Hospital
Rotterdam
The Netherlands
Grant 'Doelmatigheidsonderzoek'
Intervention
Outcome measures
Primary outcome
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
Cumulative 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
Economic Analysis (Cost minimization analysis, CMA)
Study objective
Narcotrend 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
Study design
Dataanalysis after completion of inclusion
Intervention
Patients 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.
Dr. Molewaterplein 60
F. Weber
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7040704
f.weber@erasmusmc.nl
Dr. Molewaterplein 60
F. Weber
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7040704
f.weber@erasmusmc.nl
Inclusion criteria
Written informed consent of patients and their parents/legal representatives
Age ¡Ý12 and <17 years
Bodyweight ¡Ü 60 kg (limitation of the paediatric pharmocokinetic model)
Gastrointestinal endoscopy
Eligibility for procedural sedation
Ability of the patient to communicate in Dutch
Exclusion criteria
Primary 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 inhalation induction and general anaesthesia
Patient and/or parents unable to communicate in Dutch
Secondary exclusion criteria:
Unexpected need for inhalation induction of general anaesthesia due to major difficulties to obtain intravenous access.
Unexpected procedural events requiring endotracheal intubation
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4379 |
| NTR-old | NTR4593 |
| CCMO | NL44307.078.13 |
| OMON | NL-OMON38989 |