Clinical Trials Logo

Clinical Trial Summary

To evaluate the safety and efficacy of dexmedetomidine and compare this to a current technique commonly used at TGH for sedation in patients undergoing ablation procedures for atrial fibrillation (AF) and atrial flutter.

The investigators hypothesise that dexmedetomidine will be at least equivalent to, or more so, in terms of effectiveness and safety, when compared to midazolam and remifentanil for sedation during ablation procedures.


Clinical Trial Description

The role of ablation for chronic persistent AF has been debated amongst cardiologists for some time, and there is increasing evidence that ablation may be superior to medical management. As populations age, the rate of AF is likely to increase and therefore the numbers of ablations performed for this arrhythmia will also be expected to increase.

Ablation procedures can vary in length from one to more than 6 hours in duration and require the patient to keep still so as not to influence the mapping procedure.

Options for anaesthesia care include a general anaesthetic or sedation. Several studies have evaluated the safety of sedation for ablation, using combinations of fentanyl, midazolam and propofol. These demonstrate that the ablation procedures are well tolerated under deep sedation.

Dexmedetomidine is an attractive potential agent for this role due to its favourable respiratory pharmacodynamics and good sedation profile. Dexmedetomidine is a short acting relatively specific alpha-2 receptor agonist (alpha 2: alpha 1 = 1300:1). It has been shown to have very little effect on respiratory parameters, even at high doses.In addition, it may offer some analgesic properties and therefore minimise the need for narcotic based agents. the investigators will compare dexmedetomidine infusion and fentanyl bolus with remifentanil infusion midazolam bolus. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03451227
Study type Interventional
Source University Health Network, Toronto
Contact
Status Terminated
Phase N/A
Start date December 1, 2017
Completion date May 14, 2019

See also
  Status Clinical Trial Phase
Completed NCT02849769 - Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Completed NCT02565238 - BIO.MASTER.BioMonitor 2 Study N/A
Completed NCT04025710 - Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep) N/A
Active, not recruiting NCT05621187 - Post Market Clinical Follow-up Study for the Pamira ICD Lead Family N/A
Not yet recruiting NCT06382207 - Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs N/A
Active, not recruiting NCT01526629 - Full Automaticity and Remote Follow-up N/A
Completed NCT03850327 - BIO|CONCEPT.BIOMONITOR III N/A
Recruiting NCT04905199 - Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Completed NCT03408951 - Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Not yet recruiting NCT06327425 - MCG for Localization of Tachyarrhythmia's Origin N/A
Recruiting NCT04863664 - Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP) N/A
Not yet recruiting NCT05750108 - Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction N/A
Completed NCT02774616 - BIO|MASTER.Ilivia Family / Plexa N/A
Completed NCT00231426 - ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations Phase 4
Completed NCT02181686 - Iperia/Sentus QP Study N/A
Completed NCT02933619 - ProMRI ICD/CRT-D Post Approval Study
Completed NCT00324662 - Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA) Phase 4
Completed NCT00170274 - APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias N/A
Completed NCT03891329 - Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead N/A
Completed NCT06323499 - Outcome of Induced Atypical Atrial Flutter