There is no specific medical condition under investigation
Conditions
Interventions
Trade Name: Propofol 10 mg/ml MCT/LCT Fresenius emulsie voor injectie of infusie
Pharmaceutical Form:
INN or Proposed INN: Propofol
Other descriptive name: PROPOFOL
Concentration unit: mg/ml milligra
Sponsors
Erasmus University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent of patients and their parents/legal representatives • Age =1 and 5 and = 60 kg (limitation of the paediatric TCI model) • Gastrointestinal endoscopy • Eligibility for PS • Ability of the patients' parents or legal guardians and patients = 6 years 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 PS, need for inhalation induction and general anaesthesia • Parents/ legal guardians and/or patients = 6 years unable to communicate in Dutch Secondary exclusion criteria • Unexpected need for inhalation induction of general anaesthesia due to major difficulties to ob-tain intravenous access. • Unexpected procedural events requiring endotracheal intubation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The time interval between the end of anaesthetic drug application and the moment when discharge criteria from the operating room are met (Steward Score =3) is compared between the study groups. ;Timepoint(s) of evaluation of this end point: immediately after the end of the endoscopic procedure;Main Objective: The primary objective of this study is the effect of Narcotrend Index (NI) monitoring on the speed of recovery from Procedural Sedation (PS) for paediatric gastrointestinal endoscopy (PGE). Speed of recovery is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the operating room are met.;Secondary Objective: Secondary endpoints are: • Anaesthetic drug consumption • Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthe¬sia care unit • Posthoc intergroup comparison of hypnotic depth as measured by NI • Recall of events during the procedure (awareness), only in patients > 6 years. • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 ;Timepoint(s) of evaluation of this end point: On the PACU and (2nd and 3rd interview) at days 1 and 14 after the procedure | — |
Countries
Netherlands
Contacts
Public ContactPaediatric Anaesthesia Unit
Erasmus University Medical Center
Outcome results
None listed