Clinical trial NCT03451227: Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures
Official title: A Pilot Study to Investigate the Efficacy and Safety of Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures for Treatment of a Tachyarrhythmia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tachyarrhythmia
Keywords: Sedation, Analgesia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, single blind, randomised controlled study looking at the feasibility of dexmedetomidine for sedation during ablation procedures at Toronto General Hospital.
Primary purpose: BASIC_SCIENCE

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) 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Number of haemodynamic events requiring intervention
timeFrame: up to 24 hours
measure: Number of respiratory events requiring intervention
timeFrame: up to 24 hours
Secondary outcomes:
measure: Intraoperative pain scores
timeFrame: up to 24 hours
measure: Intraoperative sedation scores
timeFrame: up to 24 hours
measure: Patient satisfaction
timeFrame: up to 48 hours
measure: Recovery time
timeFrame: up to 24 hours
measure: Length of stay in the recovery unit
timeFrame: up to 24 hours
measure: Analgesia requirements
timeFrame: up to 24 hours
measure: Post operative nausea and vomiting (PONV)
timeFrame: up to 24 hours
measure: Itch
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, Univerity health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: George Djaiani, MD
role: PRINCIPAL_INVESTIGATOR
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