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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Group | Experimental | 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). |
|
| Remifentanil Group | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine group | Drug | The study drug dexmedetomidine (PrecedexTM) will be infused at 0.2-1mcg/kg/hour from the start of the case. The dexmedetomidine infusion will stop at completion of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of haemodynamic events requiring intervention | a.Hypotension i. A decrease of 30% or more from baseline ii. Or absolute cut off values of
| up to 24 hours |
| Number of respiratory events requiring intervention | Respiratory events requiring intervention
| up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative pain scores |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Djaiani, MD | Toronto General Hospital, University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital, Univerity health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16116072 | Background | Verma A, Natale A. Should atrial fibrillation ablation be considered first-line therapy for some patients? Why atrial fibrillation ablation should be considered first-line therapy for some patients. Circulation. 2005 Aug 23;112(8):1214-22; discussion 1231. doi: 10.1161/CIRCULATIONAHA.104.478263. No abstract available. | |
| 23207492 |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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This is a prospective, single blind, randomised controlled study looking at the feasibility of dexmedetomidine for sedation during ablation procedures at Toronto General Hospital.
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Patients will be randomly allocated (computer generated) to receive either a dexmedetomidine infusion or a remifentanil infusion.
The patient, interventional cardiologist and data analyser will be blinded to the drugs given. The anaesthesia care provider will not be blinded
| Remifentanil Group | Drug | 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). The infusion will be stopped at the end of the procedure. |
|
| up to 24 hours |
| Intraoperative sedation scores |
| up to 24 hours |
| Patient satisfaction | Assessed with the Iowa Satisfaction with Anaesthesia scale 24 hours post procedure b. Assessor blinded to technique c. To include direct questioning regarding the patients willingness to undergo the same procedure again using the same technique Iowa Satisfaction with Anaesthesia scale Ref: Dexter F, Aker J, Wright W. Development of a measure of patient satisfaction with monitored anaesthetic care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology 1997; 87: 865-73. Patient assessment
| up to 48 hours |
| Recovery time | Time from stopping infusion to a SAS score of ≥4 | up to 24 hours |
| Length of stay in the recovery unit | Total time spent in recovery until appropriate discharge criteria are met and patient is discharged to the ward | up to 24 hours |
| Analgesia requirements | Quantity of opioids required i. Intraoperatively ii. In recovery iii. In the first 24 hours post op | up to 24 hours |
| Post operative nausea and vomiting (PONV) |
| up to 24 hours |
| Itch | Any complaints of itch during the procedure and 24 hours post operatively | up to 24 hours |
| Di Biase L, Santangeli P, Natale A. How to ablate long-standing persistent atrial fibrillation? Curr Opin Cardiol. 2013 Jan;28(1):26-35. doi: 10.1097/HCO.0b013e32835b59bb. |
| 19995881 | Background | Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7. |
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| 21055479 | Background | Di Biase L, Conti S, Mohanty P, Bai R, Sanchez J, Walton D, John A, Santangeli P, Elayi CS, Beheiry S, Gallinghouse GJ, Mohanty S, Horton R, Bailey S, Burkhardt JD, Natale A. General anesthesia reduces the prevalence of pulmonary vein reconnection during repeat ablation when compared with conscious sedation: results from a randomized study. Heart Rhythm. 2011 Mar;8(3):368-72. doi: 10.1016/j.hrthm.2010.10.043. Epub 2010 Nov 2. |
| 19808454 | Background | Di Biase L, Saenz LC, Burkhardt DJ, Vacca M, Elayi CS, Barrett CD, Horton R, Bai R, Siu A, Fahmy TS, Patel D, Armaganijan L, Wu CT, Kai S, Ching CK, Phillips K, Schweikert RA, Cummings JE, Arruda M, Saliba WI, Dodig M, Natale A. Esophageal capsule endoscopy after radiofrequency catheter ablation for atrial fibrillation: documented higher risk of luminal esophageal damage with general anesthesia as compared with conscious sedation. Circ Arrhythm Electrophysiol. 2009 Apr;2(2):108-12. doi: 10.1161/CIRCEP.108.815266. Epub 2009 Feb 13. |
| 22054234 | Background | Wutzler A, Rolf S, Huemer M, Parwani AS, Boldt LH, Herberger E, Hohenbichler K, Dietz R, Haverkamp W. Safety aspects of deep sedation during catheter ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2012 Jan;35(1):38-43. doi: 10.1111/j.1540-8159.2011.03260.x. Epub 2011 Nov 6. |
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| 9357889 | Background | Dexter F, Aker J, Wright WA. Development of a measure of patient satisfaction with monitored anesthesia care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology. 1997 Oct;87(4):865-73. doi: 10.1097/00000542-199710000-00021. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |