The effect of special brainwaves may reduce sedation level in childre
Phase 1
- Conditions
- Children (> 1a) who are undergoing lower body surgery in caudal anesthesia require additional sedation to maintain an adequate intraoperative sedation level. Audio-visual entrainment does have a positive influence on functions of the brain and can be used to produce sedation. We would like to prove that with the help of this audio-visual entrainment the amount of sedation medication can be reduced.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-005303-40-AT
- Lead Sponsor
- Medizinsche Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
•Planned lower body surgery will be done with caudal anesthesia and propofol sedation
•Age between 1 and 6 years (with a maximum weight of 25kg)
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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
•Children’s / parent's refusal
•Children suffering from neurological diseases e.g. epilepsy who get administered neurological, hypnotic medication regularly
•Contraindications for a propofol sedation regime
•Children suffering from related harm or deafness
•Brain injuries in patient´s medical history
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