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.
Conditions
Interventions
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 descript
Sponsors
Erasmus University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) ;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.;Timepoint(s) of evaluation of this end point: Immediately after the endoscopic procedure;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Contacts
Public ContactPaediatric Anaesthesia - Sophia
Erasmus University Medical Center
Outcome results
None listed