Endoscopic examination of the digestive tract in children under sedation with advanced monitoring equipment
- Conditions
- 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.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-002122-23-NL
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method