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

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2016
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. CONDITION: Sedation, Children, Propofol, EEG, Endoscopy ; ; 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 ; INCLUSION CRITERIA: Written 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
Epistemonikos ID: 938c0c9f337bd4126c24d72bfa6aafec2dd4ea9b
First added on: Aug 24, 2024