drugset / Trial / NCT00508118
NICardipine Neuroprotection in AortiC Surgery (NICNACS)
RandomizedParallel-groupTriple-blindTreatment
Summary
Objective The objective of this study is to discover whether an infusion of nicardipine is able to reduce the time taken to achieve electrocerebral silence (ECS) during cardiopulmonary bypass (CPB) for aortic surgery. Hypothesis By inhibiting cold-induced cerebral vasoconstriction, nicardipine will maintain cerebral blood flow and allow more rapid cooling of the brain during CPB. This will manifest as a reduction in the time taken to achieve ECS and also as a reduction in overall CPB time.
Timeline
- Start
- 2008-01
- Primary completion
- 2008-04
- Completion
- 2008-04
Publications
- Background Guerit JM, Verhelst R, Rubay J, el Khoury G, Noirhomme P, Baele P, Dion R. The use of somatosensory evoked potentials to determine the optimal degree of hypothermia during circulatory arrest. J Card Surg. 1994 Sep;9(5):596-603. doi: 10.1111/j.1540-8191.1994.tb00892.x.
- Background Ghariani S, Liard L, Spaey J, Noirhomme PH, El Khoury GA, de Tourtchaninoff M, Dion RA, Guerit JM. Retrospective study of somatosensory evoked potential monitoring in deep hypothermic circulatory arrest. Ann Thorac Surg. 1999 Jun;67(6):1915-8; discussion 1919-21. doi: 10.1016/s0003-4975(99)00413-0.
- Background Fleck TM, Czerny M, Hutschala D, Koinig H, Wolner E, Grabenwoger M. The incidence of transient neurologic dysfunction after ascending aortic replacement with circulatory arrest. Ann Thorac Surg. 2003 Oct;76(4):1198-202. doi: 10.1016/s0003-4975(03)00832-4.
- Background Dahlbacka S, Makela J, Kaakinen T, Alaoja H, Heikkinen J, Laurila P, Kiviluoma K, Salomaki T, Tuominen H, Ohtonen P, Lepola P, Biancari F, Juvonen T. Propofol is associated with impaired brain metabolism during hypothermic circulatory arrest: an experimental microdialysis study. Heart Surg Forum. 2006;9(4):E710-8; discussion E718. doi: 10.1532/HSF98.20061022.
- Background Hirotani T, Kameda T, Kumamoto T, Shirota S. Aortic arch repair using hypothermic circulatory arrest technique associated with pharmacological brain protection. Eur J Cardiothorac Surg. 2000 Nov;18(5):545-9. doi: 10.1016/s1010-7940(00)00533-9.
- Background Khaladj N, Peterss S, Oetjen P, von Wasielewski R, Hauschild G, Karck M, Haverich A, Hagl C. Hypothermic circulatory arrest with moderate, deep or profound hypothermic selective antegrade cerebral perfusion: which temperature provides best brain protection? Eur J Cardiothorac Surg. 2006 Sep;30(3):492-8. doi: 10.1016/j.ejcts.2006.05.031. Epub 2006 Jul 20.
- Background Levy WJ, Pantin E, Mehta S, McGarvey M. Hypothermia and the approximate entropy of the electroencephalogram. Anesthesiology. 2003 Jan;98(1):53-7. doi: 10.1097/00000542-200301000-00012.
- Background Pokela M, Jantti V, Lepola P, Romsi P, Rimpilainen J, Kiviluoma K, Salomaki T, Vainionpaa V, Biancari F, Hirvonen J, Kaakinen T, Juvonen T. EEG burst recovery is predictive of brain injury after experimental hypothermic circulatory arrest. Scand Cardiovasc J. 2003 Jun;37(3):154-7. doi: 10.1080/14017430310006956.
- Background Puri GD, Bagchi A, Anandamurthy B, Dhaliwal RS. The Bispectral Index and induced hypothermia--electrocerebral silence at an unusually high temperature. Anaesth Intensive Care. 2003 Oct;31(5):578-80. doi: 10.1177/0310057X0303100515.
- Background Sakamoto T, Hatsuoka S, Stock UA, Duebener LF, Lidov HG, Holmes GL, Sperling JS, Munakata M, Laussen PC, Jonas RA. Prediction of safe duration of hypothermic circulatory arrest by near-infrared spectroscopy. J Thorac Cardiovasc Surg. 2001 Aug;122(2):339-50. doi: 10.1067/mtc.2001.115242.
- Background Speziali G, Russo P, Davis DA, Wagerle LC. Hypothermia enhances contractility in cerebral arteries of newborn lambs. J Surg Res. 1994 Jul;57(1):80-4. doi: 10.1006/jsre.1994.1114.
- Background Stecker MM, Cheung AT, Pochettino A, Kent GP, Patterson T, Weiss SJ, Bavaria JE. Deep hypothermic circulatory arrest: I. Effects of cooling on electroencephalogram and evoked potentials. Ann Thorac Surg. 2001 Jan;71(1):14-21. doi: 10.1016/s0003-4975(00)01592-7.
- Background Stecker MM, Cheung AT, Pochettino A, Kent GP, Patterson T, Weiss SJ, Bavaria JE. Deep hypothermic circulatory arrest: II. Changes in electroencephalogram and evoked potentials during rewarming. Ann Thorac Surg. 2001 Jan;71(1):22-8. doi: 10.1016/s0003-4975(00)02021-x.
- Background Stecker MM, Escherich A, Patterson T, Bavaria JE, Cheung AT. Effects of acute hypoxemia/ischemia on EEG and evoked responses at normothermia and hypothermia in humans. Med Sci Monit. 2002 Apr;8(4):CR223-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicardipine | Small molecule | 5 mg | — |