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Atrial FibrillationPhase 4NCT03844841

The Deep Sedation for Ablation Study

A Phase 4 study testing Propofol and Dexmedetomidine in people with Atrial Fibrillation and Ablation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Ablation, Sedation
What is being tested?
Propofol and Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSwitzerland
Study dates
1 Jul 2019to 31 Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • Severe heart failure (LVEF ≤ 30%)
  • Indication for general anaesthesia
  • Pregnant or breast-feeding women

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Cardiology, University Hospital Inselspital Bern

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

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

Read the 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.

Keywords
Atrial Fibrillation, Ablation, Sedation, Anesthesia, Propofol, Dexmedetomidine
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    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.

  • DexmedetomidineDrug

    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.

Study groups in NCT03844841
Study groupRoleWhat they receive
PropofolActive comparatorActive agent: Propofolum (2,6-Diisopropylphenol). Route of administration: intravenous
Receives: Drug: Propofol
DexmedetomidineActive comparatorActive agent: Dexmedetomidinum ut Dexmedetomidini hydrochloridum. Route of administration: intravenous
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    • 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

    Measured: within 24 hours after completion of procedure

Secondary outcomes (14)

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

    All single components of the primary endpoint

    Measured: within 24 hours after completion of procedure

  2. Other complications

    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]

    Measured: from start until end of ablation procedure

  3. Opiod dose

    Opiod dose required for analgesia [ug]

    Measured: from start until end of ablation procedure

  4. Procedure duration

    Total duration of the procedure [minutes]

    Measured: from start until end of ablation procedure

  5. Fluoroscopy time

    Duration of fluoroscopy [minutes]

    Measured: from start until end of ablation procedure

  6. General sedation efficacy: occurrence and number of shiftings

    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]

    Measured: from start until end of ablation procedure

  7. Sedation depth

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

    Measured: from start until end of ablation procedure

  8. Blood pressure

    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]

    Measured: from start until end of ablation procedure

  9. Heart rate

    Mean heart rate during sedation and mean drop of heart rate (pre-procedural heart rate minus mean heart rate during sedation) [beats per minute]

    Measured: from start until end of ablation procedure

  10. Refractory period

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

    Measured: from start until end of ablation procedure

  11. Wenckebach point

    Wenckebach point of the atrioventricular node [ms]

    Measured: from start until end of ablation procedure

  12. Arrhythmia inducibility

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

    Measured: from start until end of ablation procedure

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

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

    Measured: within 24 hours after completion of procedure

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

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

    Measured: within 24 hours after completion of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2019
  2. Study start1 Jul 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03844841
Sponsor's protocol ID
2018-02128
Other IDs
2018
Status last verified
Jan 2021
First submitted
30 Oct 2018
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Servatius H, Kueffer T, Erdoes G, Seiler J, Tanner H, Noti F, Haeberlin A, Madaffari A, Branca M, Dutschler S, Theiler L, Reichlin T, Roten L. Electrophysiological differences of randomized deep sedation with dexmedetomidine versus propofol. BMC Anesthesiol. 2024 Jul 31;24(1):263. doi: 10.1186/s12871-024-02647-x.

    PubMed 39085782

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol and Dexmedetomidine in people with Atrial Fibrillation and Ablation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Incidence of Sedation-Emergent Adverse Events (Combined Safety Endpoint) (time frame: within 24 hours after completion of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03844841, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.

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