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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03451227
Other study ID # 13-6972-B
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date May 14, 2019

Study information

Verified date May 2019
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date May 14, 2019
Est. primary completion date March 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine group
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.
Remifentanil Group
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.

Locations

Country Name City State
Canada Toronto General Hospital, Univerity health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (38)

Alhashemi JA. Dexmedetomidine vs midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006 Jun;96(6):722-6. Epub 2006 Apr 4. — View Citation

Angst MS, Ramaswamy B, Davies MF, Maze M. Comparative analgesic and mental effects of increasing plasma concentrations of dexmedetomidine and alfentanil in humans. Anesthesiology. 2004 Sep;101(3):744-52. — View Citation

Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. — View Citation

Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-8, table of contents. — View Citation

Belleville JP, Ward DS, Bloor BC, Maze M. Effects of intravenous dexmedetomidine in humans. I. Sedation, ventilation, and metabolic rate. Anesthesiology. 1992 Dec;77(6):1125-33. — View Citation

Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. — View Citation

Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27. — View Citation

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. — View Citation

Cheung CW, Ying CL, Chiu WK, Wong GT, Ng KF, Irwin MG. A comparison of dexmedetomidine and midazolam for sedation in third molar surgery. Anaesthesia. 2007 Nov;62(11):1132-8. — View Citation

Cortinez LI, Hsu YW, Sum-Ping ST, Young C, Keifer JC, Macleod D, Robertson KM, Wright DR, Moretti EW, Somma J. Dexmedetomidine pharmacodynamics: Part II: Crossover comparison of the analgesic effect of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1077-83. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Drabek T, Nemec J. Anesthetic management of electrophysiological procedures for heart failure. Int Anesthesiol Clin. 2012 Summer;50(3):22-42. doi: 10.1097/AIA.0b013e3182603e95. Review. — View Citation

Dupanovic M, Lakkireddy D, Emert MP, Krebill R. Utility of dexmedetomidine in sedation for radiofrequency ablation of atrial fibrillation. J Perianesth Nurs. 2013 Jun;28(3):144-50. doi: 10.1016/j.jopan.2012.10.005. — View Citation

Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. — View Citation

Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. — View Citation

Hogue CW Jr, Talke P, Stein PK, Richardson C, Domitrovich PP, Sessler DI. Autonomic nervous system responses during sedative infusions of dexmedetomidine. Anesthesiology. 2002 Sep;97(3):592-8. — View Citation

Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. — View Citation

Jalowiecki P, Rudner R, Gonciarz M, Kawecki P, Petelenz M, Dziurdzik P. Sole use of dexmedetomidine has limited utility for conscious sedation during outpatient colonoscopy. Anesthesiology. 2005 Aug;103(2):269-73. — View Citation

Kaygusuz K, Gokce G, Gursoy S, Ayan S, Mimaroglu C, Gultekin Y. A comparison of sedation with dexmedetomidine or propofol during shockwave lithotripsy: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):114-9, table of contents. doi: 10.1213/01.ane.0000296453.75494.64. — View Citation

Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. Review. — View Citation

Kottkamp H, Hindricks G, Eitel C, Müller K, Siedziako A, Koch J, Anastasiou-Nana M, Varounis C, Arya A, Sommer P, Gaspar T, Piorkowski C, Dagres N. Deep sedation for catheter ablation of atrial fibrillation: a prospective study in 650 consecutive patients. J Cardiovasc Electrophysiol. 2011 Dec;22(12):1339-43. doi: 10.1111/j.1540-8167.2011.02120.x. Epub 2011 Jun 21. — View Citation

McCutcheon CA, Orme RM, Scott DA, Davies MJ, McGlade DP. A comparison of dexmedetomidine versus conventional therapy for sedation and hemodynamic control during carotid endarterectomy performed under regional anesthesia. Anesth Analg. 2006 Mar;102(3):668-75. — View Citation

Okawa K, Ichinohe T, Kaneko Y. A comparison of propofol and dexmedetomidine for intravenous sedation: a randomized, crossover study of the effects on the central and autonomic nervous systems. Anesth Analg. 2010 Feb 1;110(2):415-8. doi: 10.1213/ANE.0b013e3181c88ba0. Epub 2009 Dec 10. — View Citation

Prachanpanich N, Apinyachon W, Ittichaikulthol W, Moontripakdi O, Jitaree A. A comparison of dexmedetomidine and propofol in Patients undergoing electrophysiology study. J Med Assoc Thai. 2013 Mar;96(3):307-11. — View Citation

Riker RR, Picard JT, Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Crit Care Med. 1999 Jul;27(7):1325-9. — View Citation

Rozet I, Muangman S, Vavilala MS, Lee LA, Souter MJ, Domino KJ, Slimp JC, Goodkin R, Lam AM. Clinical experience with dexmedetomidine for implantation of deep brain stimulators in Parkinson's disease. Anesth Analg. 2006 Nov;103(5):1224-8. — View Citation

Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15. — View Citation

Salukhe TV, Willems S, Drewitz I, Steven D, Hoffmann BA, Heitmann K, Rostock T. Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation. Europace. 2012 Mar;14(3):325-30. doi: 10.1093/europace/eur328. Epub 2011 Oct 23. — View Citation

Sichrovsky TC, Mittal S, Steinberg JS. Dexmedetomidine sedation leading to refractory cardiogenic shock. Anesth Analg. 2008 Jun;106(6):1784-6. doi: 10.1213/ane.0b013e318172fafc. — View Citation

Talke P, Li J, Jain U, Leung J, Drasner K, Hollenberg M, Mangano DT. Effects of perioperative dexmedetomidine infusion in patients undergoing vascular surgery. The Study of Perioperative Ischemia Research Group. Anesthesiology. 1995 Mar;82(3):620-33. — View Citation

Tsai CJ, Chu KS, Chen TI, Lu DV, Wang HM, Lu IC. A comparison of the effectiveness of dexmedetomidine versus propofol target-controlled infusion for sedation during fibreoptic nasotracheal intubation. Anaesthesia. 2010 Mar;65(3):254-9. doi: 10.1111/j.1365-2044.2009.06226.x. Epub 2010 Jan 22. — View Citation

Vann MA, Ogunnaike BO, Joshi GP. Sedation and anesthesia care for ophthalmologic surgery during local/regional anesthesia. Anesthesiology. 2007 Sep;107(3):502-8. Review. — View Citation

Venn M, Newman J, Grounds M. A phase II study to evaluate the efficacy of dexmedetomidine for sedation in the medical intensive care unit. Intensive Care Med. 2003 Feb;29(2):201-7. Epub 2002 Nov 22. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 38 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of haemodynamic events requiring intervention a.Hypotension i. A decrease of 30% or more from baseline ii. Or absolute cut off values of
SBP < 80mmHg
DBP <40mmHg iii. Number of events and total dose of phenylephrine or ephedrine administered.
b. Hypertension i. An increase in Systolic blood pressure 30% or more from baseline ii. Or an absolute cut off value of > 180mmHg iii. Total number of events c. Bradycardia i. A decrease of 30% or more from baseline ii. Or absolute cut off values of < 40bpm iii. Total number of events and total dose of glycopyrolate or atropine administered.
up to 24 hours
Primary Number of respiratory events requiring intervention Respiratory events requiring intervention
Respiratory rate < 6 breaths/min
Airway obstruction requiring manual support
Airway obstruction requiring guedel insertion
Apnoea (cessation of respiration >10seconds)
Hypoxia (saturations <90% for >20 seconds)
up to 24 hours
Secondary Intraoperative pain scores VAS score (visual analog score). VAS is a simple assessment tool consisting of a 10 cm line with 0 on one end, representing no pain, and 10 on the other, representing the worst pain ever experienced, which a patient indicates so the clinician knows the severity of his or her pain. Pain scores using a VAS scale ranging from zero to ten will be recorded every 30 minutes
Total amount of additional fentanyl used intraoperatively
up to 24 hours
Secondary Intraoperative sedation scores Sedation Agitation Scale (SAS) scale range from 1 to 7 will be recorded every 5 minutes. The SAS scale is outlined below with an optimal score of 4 for procedural sedation.
Ref: Riker RR, Picard JT and Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Critical Care Medicine 1999;27(7):1325-1329.
Total amount of additional midazolam used intraoperatively
up to 24 hours
Secondary 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
I threw up or felt like throwing up
I would have the same anaesthetic again
I itched
I felt relaxed
I felt pain
I felt safe
I was too hot or cold
I was satisfied with the anesthesia care
I felt pain during the surgery
I felt good
I hurt
up to 48 hours
Secondary Recovery time Time from stopping infusion to a SAS score of =4 up to 24 hours
Secondary 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
Secondary Analgesia requirements Quantity of opioids required i. Intraoperatively ii. In recovery iii. In the first 24 hours post op up to 24 hours
Secondary Post operative nausea and vomiting (PONV) Subjective or objective evidence of PONV lasting > 30 mins
Antiemetic therapy administered
up to 24 hours
Secondary Itch Any complaints of itch during the procedure and 24 hours post operatively up to 24 hours
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