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

University Health Network, Toronto

Status: Terminated

Conditions: Tachyarrhythmia

Treatments: Drug: Dexmedetomidine group; Drug: Remifentanil Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03451227

13-6972-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups

Dexmedetomidine Group

Experimental group

Description:

The study drug dexmedetomidine (PrecedexTM) is supplied as dexmedetomidine HCL 200mcg/vial (100mcg/ml). This will be added to 98 ml 0.9% NaCl to achieve a concentration of 2mcg/ml and infused at 0.2-1mcg/kg/hour from the start of the case. The infusion rate will be commenced at 1mcg/kg/hour in those less than or equal to 65 years of age, and at 0.7mcg/kg/hr in those greater than 65 years of age, and then titrated based on the intraoperative sedation scores (to achieve a Sedation and Agitation scale (SAS) score of less than or equal to 4) and cardiovascular parameters (within 30% of baseline).

Treatment:

Drug: Dexmedetomidine group

Remifentanil Group

Active Comparator group

Description:

Remifentanil HCL will be infused at 0.01-0.2 mcg/kg/min titrated to sedation level (SAS less than or equal to 4) and cardiovascular parameters (within 30% of baseline)

Treatment:

Drug: Remifentanil Group