Comparison between two different sedation strategies (propofol versus propofol plus ketamine) in deep sedation managed by non anesthesiologists. - Propofol versus propofol plus ketamine in non anesthesiologists managed deep sedatio
- Conditions
- Procedural deep sedation (gastrointestinal endoscopy, lumbar puncture, etc)MedDRA version: 9.1Level: LLTClassification code 10002091Term: Anaesthesia
- Registration Number
- EUCTR2008-001493-32-IT
- Lead Sponsor
- ISTITUTO PER L'INFANZIA BURLO GAROFOLO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
ASA (American Society of Anesthesiology)1 and 2 children (1-18 years) scheduled for elective deep sedation for diagnostic procedures
Are the trial subjects under 18? yes
Number of subjects for this age range:
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 ASA 3 and more, presence of risk factors for loss of airway patency.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To asses safety and efficacy of two different strategies of deep sedation managed by non anesthesiologists. Number of sedations successfully performed, side effects.;Secondary Objective: To evaluate quality of sedation (pain during propofol injection, recovery time, characteristics of arousal, post-sedation vomiting), reduction in propofol dosage/kg, costs.;Primary end point(s): Number of sedations successfully managed, number and severity of fall in arterial oxygen saturation.
- Secondary Outcome Measures
Name Time Method