Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures

• Status: Terminated
• Trial end date: 2019-05-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Dexmedetomidine; Fentanyl; Midazolam; Remifentanil

Criteria

Inclusion Criteria:

• patients listed for an ablation procedure for treatment of atrial fibrillation or flutter at TGH requiring sedation provided by an anesthetist

• Valid consent

Exclusion Criteria:

• 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