The Deep Sedation for Ablation Study

Insel Gruppe AG, University Hospital Bern

Status and phase

Completed

Phase 4

Conditions

Ablation

Atrial Fibrillation

Propofol

Dexmedetomidine

Sedation

Treatments

Drug: Propofol

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03844841

2018-02128

Details and patient eligibility

About

Catheter ablation (CA) is an established therapeutic option for patients with symptomatic atrial fibrillation (AF). During the procedure, patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. However, due to the depressive effect of Propofol on the respiratory system, this regimen is not without risk. Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak effect on the respiratory system. The pharmacological profile of Dexmedetomidine may be advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.

Full description

Atrial fibrillation (AF) is the most common arrhythmia. In symptomatic patients, electroanatomic mapping aided catheter ablation (CA) is an established therapeutic option. The intervention may last several hours, during which patients are required to lie as still as possible, as inadequate patient movements disturb the electroanatomic map, prolong the intervention and increase its complication risks. Therefore patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. Despite its wide use, this regimen is not without risk, as Propofol has a pronounced depressive effect on the respiratory system.

Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak respiratory depression. By reducing sympathetic activity it also reduces the stress response to an intervention. For these reasons, Dexmedetomidine is commonly used in intensive care units, where it has been shown to be well tolerated. Consequently, its range of application has been increasingly widened and good experience has been made with its use in transfemoral valve replacement procedures or gastroenterological interventions.

The pharmacological profile of dexmedetomidine may be also advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years
Informed consent as documented by signature
Catheter ablation of atrial fibrillation at the Department of Cardiology, Inselspital Bern

Exclusion criteria

Contraindication to sedation by the electrophysiologist
Contraindications to either propofol or dexmedetomidine sedation
Contraindication for targeted controlled propofol infusion (BMI > 35)
American Society of Anesthesiologists (ASA) classification > III
Advanced heart block (second or third degree), if no pacemaker or internal cardioverter defibrillator is implanted
Arterial hypotension (mean < 80 mmHg)
Severe heart failure (LVEF ≤ 30%)
Indication for general anaesthesia
Pregnant or breast-feeding women