Status:
TERMINATED
Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures
Lead Sponsor:
University Health Network, Toronto
Conditions:
Tachyarrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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)...
Detailed 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 population...
Eligibility Criteria
Inclusion
- patients listed for an ablation procedure for treatment of atrial fibrillation or flutter at TGH requiring sedation provided by an anesthetist
- Valid consent
Exclusion
- Baseline HR \<40
- Baseline SBP \< 80mmHg
- Baseline SBP \> 180mmHg
- Second or third degree heart block unless pacemaker in situ
- Uncontrolled heart failure/severe LV dysfunction (Ejection fraction \< 40%)
- Severe hepatic dysfunction (Transaminases greater than 2 times the upper limit of normal)
- Renal dysfunction: estimated GFR \< 30ml/min, or requiring dialysis
- Allergy to any of the study drugs (dexmedetomidine, remifentanil, fentanyl, midazolam)
- Cognitive impairment precluding ability to tolerate sedation and comply with assessment methods
- Requirement for general anaesthetic for the procedure
- Pregnancy or breast feeding mothers
- Chronic use or addiction to opioids
- \< 18 years of age
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03451227
Start Date
December 1 2017
End Date
May 14 2019
Last Update
May 16 2019
Active Locations (1)
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1
Toronto General Hospital, Univerity health Network
Toronto, Ontario, Canada, M5G 2C4