The Deep Sedation for Ablation Study

NCT03844841 | Completed Phase 4

• 1 other identifier: 2018-02128
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Ablation; Sedation; Propofol; Dexmedetomidine

Keywords

Atrial Fibrillation; Ablation; Sedation; Anesthesia; Propofol; Dexmedetomidine

Outcome Measures

Primary Outcomes (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

  within 24 hours after completion of procedure

Secondary Outcomes (14)

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

  within 24 hours after completion of procedure

• Other complications

  from start until end of ablation procedure

• Opiod dose

  from start until end of ablation procedure

• Procedure duration

  from start until end of ablation procedure

• Fluoroscopy time

  from start until end of ablation procedure

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Active agent: Propofolum (2,6-Diisopropylphenol). Route of administration: intravenous

Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

Active agent: Dexmedetomidinum ut Dexmedetomidini hydrochloridum. Route of administration: intravenous

Drug: Dexmedetomidine

Interventions

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.

Propofol

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.

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Cardiology, University Hospital Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39085782 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Helge Servatius, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: February 19, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)