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

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.

Timeline

Start

2017-12-01

Primary completion

2018-03-12

Completion

2019-05-14

Outcome

Outcome not reported

Stopped (Enrollment): “Unable to recruit eligible participants”

Publications

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• 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.
• 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.
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• Background 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. doi: 10.1097/00000542-200008000-00016.
• Background 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.
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• Background 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. doi: 10.1007/s00134-002-1579-9. Epub 2002 Nov 22.
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• Background 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. doi: 10.1097/00000542-200411000-00005.
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