Clinical trial NCT03844841: The Deep Sedation for Ablation Study
Official title: DExmEdetomidine Sedation Versus Propofol SEDATION FOR Catheter ABLATION of Atrial Fibrillation Under a Cardiologist Supervision: A Randomized Controlled Pilot STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Ablation
Sedation
Propofol
Dexmedetomidine
Keywords: Atrial Fibrillation
Ablation
Sedation
Anesthesia
Propofol
Dexmedetomidine
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined Incidence of Sedation-Emergent Adverse Events (Combined Safety Endpoint)
timeFrame: within 24 hours after completion of procedure
Secondary outcomes:
measure: Incidence of Sedation-Emergent Adverse Events (Individual Safety Endpoints)
timeFrame: within 24 hours after completion of procedure
measure: Other complications
timeFrame: from start until end of ablation procedure
measure: Opiod dose
timeFrame: from start until end of ablation procedure
measure: Procedure duration
timeFrame: from start until end of ablation procedure
measure: Fluoroscopy time
timeFrame: from start until end of ablation procedure
measure: General sedation efficacy: occurrence and number of shiftings
timeFrame: from start until end of ablation procedure
measure: Sedation depth
timeFrame: from start until end of ablation procedure
measure: Blood pressure
timeFrame: from start until end of ablation procedure
measure: Heart rate
timeFrame: from start until end of ablation procedure
measure: Refractory period
timeFrame: from start until end of ablation procedure
measure: Wenckebach point
timeFrame: from start until end of ablation procedure
measure: Arrhythmia inducibility
timeFrame: from start until end of ablation procedure
measure: Patient satisfaction: Patient Satisfaction with Sedation Instrument (PSSI) [score]
timeFrame: within 24 hours after completion of procedure
measure: Cardiologist satisfaction: Clinician Satisfaction with Sedation Instrument (CSSI) [score]
timeFrame: within 24 hours after completion of procedure
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Cardiology, University Hospital Inselspital Bern
state: Bern (Kanton)
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Helge Servatius, MD
role: PRINCIPAL_INVESTIGATOR
References: