The influence of electroencephalographic Narcotrend Index™- guidance of of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in paediatric patients

INTERVENTION: Trade Name: Propofol 10 mg/ml MCT/LCT Fresenius emulsie voor injectie of infusie Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Propofol CAS Number: 2078‐54‐8 Other descriptive name: PROPOFOL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] There is no medical condition which is under investigation. Paediatric patients, scheduled for gastrointestinal endoscopy under procedural sedation are eligible for inclusion. Depth of sedation will be assessed either by processed EEG analysis or by clinical surrogate parameters. Based on that assessement propofol is delivered. PRIMARY OUTCOME: Main Objective: To evaluate the impact of electroencephalographic Narcotrend™ Index (NI) monitoring on the speed of emergence and recovery from procedural sedation for paediatric gastrointestinal endoscopy. Primary end point(s): The primary objective of this study is the effect of NI monitoring on the speed of recovery from procedural sedation for paediatric gastrointestinal endoscopy (PGE). Speed of recovery is defined as the time interval between the end of anaesthetic drug application and the moment when discharge criteria from the operating room are met. Secondary Objective: Secondary Objective(s): • Cumulative propofol 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 • Detection of possible recall of events during the procedure (awareness) • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events • Economic Analysis (Cost minimization analysis, CMA) Timepoint(s) of evaluation of this end point: Immediately after the endoscopic procedure SECONDARY OUTCOME: Secondary end point(s): Cumulative propofol 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; • Detection of possible recall of events during the procedure (awareness); • Assessment of endoscopy conditions (by paediatric gastroenterologist); • Adverse events; • Economic Analysis (Cost minimization analysis, CMA) Timepoint(s) of evaluation of this end point: On the recovery room, interviews 1 and 14 days after the procedure.; Posthoc analysis of EEG data will be performed offline. INCLUSION CRITERIA: Written informed consent of patients and their parents/legal representatives • Age 12‐17 years • Bodyweight = 60 kg • Gastrointestinal endoscopy • Eligibility for procedural sedation • Ability of the patient to communicate in Dutch Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0