Examination of the gut under sedation in children between 1 and 12 years with advanced monitoring equipment
- Conditions
- There is no specific medical condition under investigationTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-000406-11-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 =1 and <12 years
•Bodyweight >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
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
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