The Deep Sedation for Ablation Study

PHASE4CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

July 1, 2019

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Atrial FibrillationAblationSedationPropofolDexmedetomidine
Interventions
DRUG

Propofol

At minimum 5 minutes before start of sedation for atrial fibrillation ablation a bolus of fentanyl (20-50 µg) will be administered. Thereafter, sedation is induced via the continuous infusion of propofol using a target-controlled infusion (TCI) pump. The effect-site propofol concentration will be initially set to 1.5 µg/ml, unless the patient is already sedated by fentanyl. Subsequently, an effect-site propofol concentration of 1 µg/ml will be chosen adjusted stepwise (using steps of 0.3 µg/ml) to reach a target score of 2-3 on the MOAA/S scale. In case of pain fentanyl can be administered bolus-wise (10-30 µg) at the cardiologists discretion.

DRUG

Dexmedetomidine

At minimum 5 minutes before start of sedation for atrial fibrillation ablation a bolus of fentanyl (20-50 µg) will be administered. Thereafter, sedation is induced with a loading dose of dexmedetomidine (0.8 µg/kg) over 10 minutes. The maintenance dexmedetomidine dose is adjusted to the appropriate sedation criteria for CA (0.4 µg/kg/h) and for a target score of 2-3 on the MOAA/S scale. In case of pain, additional fentanyl can be administered bolus-wise (10-30 µg) at the cardiologists discretion.

Trial Locations (1)

3010

Department of Cardiology, University Hospital Inselspital Bern, Bern

All Listed Sponsors
lead

Insel Gruppe AG, University Hospital Bern

OTHER

NCT03844841 - The Deep Sedation for Ablation Study | Biotech Hunter | Biotech Hunter