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NCT Number: NCT03844841

The Deep Sedation for Ablation Study

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.

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Key information

Conditions

Atrial Fibrillation Ablation Arrhythmias, Cardiac Cardiovascular Diseases Dexmedetomidine Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Propofol Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, University Hospital Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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.

Dexmedetomidine

Drug

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.

Primary outcomes

  1. Combined Incidence of Sedation-Emergent Adverse Events (Combined Safety Endpoint)

    Time frame: 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 outcomes

  1. Incidence of Sedation-Emergent Adverse Events (Individual Safety Endpoints)

    Time frame: within 24 hours after completion of procedure

    All single components of the primary endpoint

  2. Other complications

    Time frame: 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]

  3. Opiod dose

    Time frame: from start until end of ablation procedure

    Opiod dose required for analgesia [ug]

  4. Procedure duration

    Time frame: from start until end of ablation procedure

    Total duration of the procedure [minutes]

  5. Fluoroscopy time

    Time frame: from start until end of ablation procedure

    Duration of fluoroscopy [minutes]

  6. General sedation efficacy: occurrence and number of shiftings

    Time frame: 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]

  7. Sedation depth

    Time frame: from start until end of ablation procedure

    Depth of sedation assessed by the Modified Observer's Alertness/Sedation (MOAA/S) scale [mean score]

  8. Blood pressure

    Time frame: 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]

  9. Heart rate

    Time frame: 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]

  10. Refractory period

    Time frame: from start until end of ablation procedure

    Effective refractory period of the atria and atrioventricular node [ms]

  11. Wenckebach point

    Time frame: from start until end of ablation procedure

    Wenckebach point of the atrioventricular node [ms]

  12. Arrhythmia inducibility

    Time frame: from start until end of ablation procedure

    Rate of inducibility of supraventricular arrhythmias during pacing manoeuvres (number of successful/number of attempts) [%]

  13. Patient satisfaction: Patient Satisfaction with Sedation Instrument (PSSI) [score]

    Time frame: within 24 hours after completion of procedure

    Patient satisfaction as assessed by the Patient Satisfaction with Sedation Instrument (PSSI) [score]

  14. Cardiologist satisfaction: Clinician Satisfaction with Sedation Instrument (CSSI) [score]

    Time frame: within 24 hours after completion of procedure

    Cardiologist satisfaction as assessed by the Clinician Satisfaction with Sedation Instrument (CSSI) [score]

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

DExmEdetomidine Sedation Versus Propofol SEDATION FOR Catheter ABLATION of Atrial Fibrillation Under a Cardiologist Supervision: A Randomized Controlled Pilot STUDY

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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