Dexmedetomidin compared with placebo in sedation during radiofrequency catheter ablation of atrial fibrillation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023020-24-FI

Enrollment

Registered

2010-10-18

Start date

2010-11-24

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation level between dexmedetomidin and placebo during radiofrequency catheter ablation of atrial fibrillation MedDRA version: 12.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation

Interventions

Trade Name: Deksmedetomidiini (Precedex) Product Name: Precedex Pharmaceutical Form: Intravenous infusion INN or Proposed INN: dexmedetomidine hydrochlo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. allergy to dexmedetomidine, opioid analgesics or benzodiazepines 2. age>65 yrs 3. severe hypotonia

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026