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
ID
Bron
Verkorte titel
Aandoening
Sedation
Propofol
Children
Gastrointestinal endoscopy
Depth of Anaesthesia Monitoring
EEG
Ondersteuning
Sophia Children's Hospital
Rotterdam
The Netherlands
Grant 'Doelmatigheidsonderzoek'
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Doel van het onderzoek
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
Onderzoeksopzet
Dataanalysis after completion of inclusion
Onderzoeksproduct en/of interventie
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.
Publiek
Dr. Molewaterplein 60
F. Weber
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7040704
f.weber@erasmusmc.nl
Wetenschappelijk
Dr. Molewaterplein 60
F. Weber
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 7040704
f.weber@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4379 |
| NTR-old | NTR4593 |
| CCMO | NL44307.078.13 |
| OMON | NL-OMON38989 |