The Deep Sedation for Ablation Study

Phase 4

Completed

• Conditions: Sedation; Propofol; Dexmedetomidine; Atrial Fibrillation; Ablation
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT03844841
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-19
• Study Start: 2019-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Active agent: Dexmedetomidinum ut Dexmedetomidini hydrochloridum. Route of administration: intravenous
Propofol	Propofol	Active agent: Propofolum (2,6-Diisopropylphenol). Route of administration: intravenous

Primary Outcome Measures

Name	Time	Method
Combined Incidence of Sedation-Emergent Adverse Events (Combined Safety Endpoint)	within 24 hours after completion of procedure	* Number of participants with sustained bradycardia necessitating cardiac pacing; * Number of participants with Hypercapnia, defined as rise of transcutaneously measured carbon dioxide levels (tcCO2) \> 20mmHg; * Number of participants with Oxygen desaturation (\<90%) necessitating assisted ventilation or further airway management in any form (including chin lift, oropharyngeal airway, bag, and mask ventilation or intubation); * Number of participants with Hypotension necessitating termination of sedation or vasopressor administration; * Number of participants with necessity of termination or change of sedation protocol; * Number of participants with aborted procedure due to sedation issues

Secondary Outcome Measures

Name	Time	Method
Opiod dose	from start until end of ablation procedure	Opiod dose required for analgesia \[ug\]
Arrhythmia inducibility	from start until end of ablation procedure	Rate of inducibility of supraventricular arrhythmias during pacing manoeuvres (number of successful/number of attempts) \[%\]
Patient satisfaction: Patient Satisfaction with Sedation Instrument (PSSI) [score]	within 24 hours after completion of procedure	Patient satisfaction as assessed by the Patient Satisfaction with Sedation Instrument (PSSI) \[score\]
Cardiologist satisfaction: Clinician Satisfaction with Sedation Instrument (CSSI) [score]	within 24 hours after completion of procedure	Cardiologist satisfaction as assessed by the Clinician Satisfaction with Sedation Instrument (CSSI) \[score\]
General sedation efficacy: occurrence and number of shiftings	from start until end of ablation procedure	General sedation efficacy assessed by the occurrence and number of shiftings of the acquired 3D map due to patient movements, necessitating remapping \[number of events\]
Incidence of Sedation-Emergent Adverse Events (Individual Safety Endpoints)	within 24 hours after completion of procedure	All single components of the primary endpoint
Other complications	from start until end of ablation procedure	Number of complications not related to sedation (cardiac tamponade, stroke/transient ischemic attack, pericardial effusion necessitating therapeutic intervention, bleeding necessitating therapeutic intervention, others) \[number of events\]
Procedure duration	from start until end of ablation procedure	Total duration of the procedure \[minutes\]
Fluoroscopy time	from start until end of ablation procedure	Duration of fluoroscopy \[minutes\]
Sedation depth	from start until end of ablation procedure	Depth of sedation assessed by the Modified Observer's Alertness/Sedation (MOAA/S) scale \[mean score\]
Heart rate	from start until end of ablation procedure	Mean heart rate during sedation and mean drop of heart rate (pre-procedural heart rate minus mean heart rate during sedation) \[beats per minute\]
Refractory period	from start until end of ablation procedure	Effective refractory period of the atria and atrioventricular node \[ms\]
Wenckebach point	from start until end of ablation procedure	Wenckebach point of the atrioventricular node \[ms\]
Blood pressure	from start until end of ablation procedure	Mean systolic, diastolic and mean blood pressure during sedation and mean drop of blood pressure (pre-procedural blood pressure minus mean blood pressure during sedation) \[mmHg\]

Trial Locations

Locations (1)

Department of Cardiology, University Hospital Inselspital Bern; 🇨🇭 Bern, Bern (Kanton), Switzerland