Dexmedetomidin compared with placebo in sedation during radiofrequency catheter ablation of atrial fibrillatio
Phase 1
- Conditions
- Sedation level between dexmedetomidin and placebo during radiofrequency catheter ablation of atrial fibrillationMedDRA version: 12.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
- Registration Number
- EUCTR2010-023020-24-FI
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1.patient with paroksysmal atrial fibrillation
2.radiofrequency ablation of atrial fibrillation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. allergy to dexmedetomidine, opioid analgesics or benzodiazepines
2. age>65 yrs
3. severe hypotonia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Sedation level;Secondary Objective: Pain, how unpleasent the catheter ablation is?, sedative medication, vital signs;Primary end point(s): sedation level caused by dexmedetomidine
- Secondary Outcome Measures
Name Time Method