None listed
Conditions
Interventions
None listed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men or women, age = 18 years 2) Diagnosed with atrial fibrillation which suitable for catheter ablation 3) Informed consent as documented by signature
Exclusion criteria
Exclusion criteria: Unsuited for ODNA sedation: any of the followings 1) Severe heart failure (Left ventricular ejection fraction 35 kg/m² 3) American Society of Anesthesiology (ASA) classification > III 4) Advanced heart block (second or third degree) without a pacemaker or internal cardioverter defibrillator implanted 5) Arterial hypotension (systolic blood pressure < 80 mmHg) 6) Indication for general anesthesia 7) Contraindication to sedation by the electrophysiologist 8) Contraindications to either propofol or remifentanil 9) Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Unexpected discontinuation or change of sedation protocol -Respiratory salvage intervention -Significant hemodynamic changes (hypotension (systolic blood pressure < 80mmHg), or need for continuous vasopressor infusion) -Bradycardia (HR<40bpm, HR<20% compared with baseline, or need for cardiac pacing) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Individual components of primary endpoints - Rescue medication for hemodynamic changes (e.g ephedrine, vasopressor) - Respiratory depression (SpO2<90, during 15s) - Mean MOAA/S score, Minimal MOAA/S score - Inability to achieve MOAA/S score =3 - Discontinuation of procedure due to sedation-related adverse events - ablation complication - Satisfaction of patients (mean Pain, max Pain, satisfaction): VAS - Sedation induction time (time between start of propofol/remifentanil infusion and vein puncture) - Time to sedation recovery: time to reach MOAA/S 5 score - Total amount of propofol and remifentanil dose - Total procedure time | — |
Countries
Korea, Republic of
Contacts
Public ContactMyoungEun Kim
Asan Medical Center
Outcome results
None listed