drugset / Trial / NCT00303433
Namenda to Prevent Post-Operative Delirium
RandomizedParallel-groupDouble-blindPrevention
Summary
Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is associated with an increased risk of mortality, increase length of stay, and more adverse outcomes in general, including increased risk of higher level of care required at discharge. Namenda, which is currently approved for moderate or severe Alzheimer's disease has a unique mechanism of action than other drugs for this condition. It may have the ability to protect the brain from more severe consequences of hypoxia, or hypoglycemia. Hence it is being looked at in this study to see if it can reduce the incidence and/or severity of delirium post-operatively.
Timeline
- Start
- 2006-03
- Primary completion
- —
- Completion
- 2006-09
Publications
- Background Schwartz TL, Masand PS. The role of atypical antipsychotics in the treatment of delirium. Psychosomatics. 2002 May-Jun;43(3):171-4. doi: 10.1176/appi.psy.43.3.171.
- Background Breitbart W, Rosenfeld B, Roth A, Smith MJ, Cohen K, Passik S. The Memorial Delirium Assessment Scale. J Pain Symptom Manage. 1997 Mar;13(3):128-37. doi: 10.1016/s0885-3924(96)00316-8.
- Background Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.
- Background Nishikawa K, Nakayama M, Omote K, Namiki A. Recovery characteristics and post-operative delirium after long-duration laparoscope-assisted surgery in elderly patients: propofol-based vs. sevoflurane-based anesthesia. Acta Anaesthesiol Scand. 2004 Feb;48(2):162-8. doi: 10.1111/j.0001-5172.2004.00264.x.
- Background Inouye SK. Delirium in hospitalized elderly patients: recognition, evaluation, and management. Conn Med. 1993 May;57(5):309-15. No abstract available.
- Background Inouye SK, Rushing JT, Foreman MD, Palmer RM, Pompei P. Does delirium contribute to poor hospital outcomes? A three-site epidemiologic study. J Gen Intern Med. 1998 Apr;13(4):234-42. doi: 10.1046/j.1525-1497.1998.00073.x.
- Background McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. doi: 10.1001/archinte.162.4.457.
- Background Inouye SK. Delirium in hospitalized older patients: recognition and risk factors. J Geriatr Psychiatry Neurol. 1998 Fall;11(3):118-25; discussion 157-8. doi: 10.1177/089198879801100302.
- Background Breitbart W, Gibson C, Tremblay A. The delirium experience: delirium recall and delirium-related distress in hospitalized patients with cancer, their spouses/caregivers, and their nurses. Psychosomatics. 2002 May-Jun;43(3):183-94. doi: 10.1176/appi.psy.43.3.183.
- Background Gustafson Y, Berggren D, Brannstrom B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30. doi: 10.1111/j.1532-5415.1988.tb04023.x.
- Background Saravay SM, Strain JJ. APM Task Force on Funding Implications of Consultation-Liaison Outcome Studies. Special series introduction: a review of outcome studies. Psychosomatics. 1994 May-Jun;35(3):227-32. doi: 10.1016/S0033-3182(94)71771-0. No abstract available.
- Background Thomas RI, Cameron DJ, Fahs MC. A prospective study of delirium and prolonged hospital stay. Exploratory study. Arch Gen Psychiatry. 1988 Oct;45(10):937-40. doi: 10.1001/archpsyc.1988.01800340065009.
- Background Schor JD, Levkoff SE, Lipsitz LA, Reilly CH, Cleary PD, Rowe JW, Evans DA. Risk factors for delirium in hospitalized elderly. JAMA. 1992 Feb 12;267(6):827-31.
- Background Cushman LA. Secondary neuropsychiatric complications in stroke: implications for acute care. Arch Phys Med Rehabil. 1988 Oct;69(10):877-9.
- Background Kishi Y, Iwasaki Y, Takezawa K, Kurosawa H, Endo S. Delirium in critical care unit patients admitted through an emergency room. Gen Hosp Psychiatry. 1995 Sep;17(5):371-9. doi: 10.1016/0163-8343(95)00056-w.
- Background Berggren D, Gustafson Y, Eriksson B, Bucht G, Hansson LI, Reiz S, Winblad B. Postoperative confusion after anesthesia in elderly patients with femoral neck fractures. Anesth Analg. 1987 Jun;66(6):497-504.
- Background Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
- Background Foreman MD. Prevention and Treatment Strategies for Delirium. Primary Psychiatry 11(11): 52-58, 2004.
- Background Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
- Background Bogardus ST Jr, Desai MM, Williams CS, Leo-Summers L, Acampora D, Inouye SK. The effects of a targeted multicomponent delirium intervention on postdischarge outcomes for hospitalized older adults. Am J Med. 2003 Apr 1;114(5):383-90. doi: 10.1016/s0002-9343(02)01569-3.
- Background Rizzo JA, Bogardus ST Jr, Leo-Summers L, Williams CS, Acampora D, Inouye SK. Multicomponent targeted intervention to prevent delirium in hospitalized older patients: what is the economic value? Med Care. 2001 Jul;39(7):740-52. doi: 10.1097/00005650-200107000-00010.
- Background Trzepacz PT. Delirium. Advances in diagnosis, pathophysiology, and treatment. Psychiatr Clin North Am. 1996 Sep;19(3):429-48. doi: 10.1016/s0193-953x(05)70299-9.
- Background Kawashima T, Yamada S. Delirium caused by donepezil: a case study. J Clin Psychiatry. 2002 Mar;63(3):250-1. doi: 10.4088/jcp.v63n0312f. No abstract available.
- Background Trzepacz PT. The neuropathogenesis of delirium. A need to focus our research. Psychosomatics. 1994 Jul-Aug;35(4):374-91. doi: 10.1016/S0033-3182(94)71759-X.
- Background Rogawski MA. What is the rationale for new treatment strategies in Alzheimer's disease? CNS Spectr. 2004 Jul;9(7 Suppl 5):6-12. doi: 10.1017/s1092852900024743.
- Background Nelson JK, Schilke DA. The evolution of psychiatric liaison nursing. Perspect Psychiatr Care. 1976 Apr-Jun;14(2):60-5. doi: 10.1111/j.1744-6163.1976.tb01536.x. No abstract available.
- Background Chase TN. Levodopa therapy: consequences of the nonphysiologic replacement of dopamine. Neurology. 1998 May;50(5 Suppl 5):S17-25. doi: 10.1212/wnl.50.5_suppl_5.s17.
- Background Harrell RG, Othmer E. Postcardiotomy confusion and sleep loss. J Clin Psychiatry. 1987 Nov;48(11):445-6.
- Background Matsushima E, Nakajima K, Moriya H, Matsuura M, Motomiya T, Kojima T. A psychophysiological study of the development of delirium in coronary care units. Biol Psychiatry. 1997 Jun 15;41(12):1211-7. doi: 10.1016/s0006-3223(96)00219-3.
- Background Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
- Background Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229.
- Background Gleason OC. Donepezil for postoperative delirium. Psychosomatics. 2003 Sep-Oct;44(5):437-8. doi: 10.1176/appi.psy.44.5.437. No abstract available.
- Background Scarpini E, Scheltens P, Feldman H. Treatment of Alzheimer's disease: current status and new perspectives. Lancet Neurol. 2003 Sep;2(9):539-47. doi: 10.1016/s1474-4422(03)00502-7.
- Background Wengel SP, Burke WJ, Roccaforte WH. Donepezil for postoperative delirium associated with Alzheimer's disease. J Am Geriatr Soc. 1999 Mar;47(3):379-80. doi: 10.1111/j.1532-5415.1999.tb03015.x. No abstract available.
- Background Moster ML, Balcer LJ. The 56th annual meeting of the American Academy of Neurology, San Francisco, California, April 24-30, 2004. J Neuroophthalmol. 2004 Dec;24(4):327-36. doi: 10.1097/00041327-200412000-00012. No abstract available.
- Background Rogawski MA, Wenk GL. The neuropharmacological basis for the use of memantine in the treatment of Alzheimer's disease. CNS Drug Rev. 2003 Fall;9(3):275-308. doi: 10.1111/j.1527-3458.2003.tb00254.x.
- Background Cepeda C, Levine MS. Dopamine and N-methyl-D-aspartate receptor interactions in the neostriatum. Dev Neurosci. 1998;20(1):1-18. doi: 10.1159/000017294.
- Background Cepeda C, Colwell CS, Itri JN, Gruen E, Levine MS. Dopaminergic modulation of early signs of excitotoxicity in visualized rat neostriatal neurons. Eur J Neurosci. 1998 Nov;10(11):3491-7. doi: 10.1046/j.1460-9568.1998.00357.x.
- Background Huang KX, Bergstrom DA, Ruskin DN, Walters JR. N-methyl-D-aspartate receptor blockade attenuates D1 dopamine receptor modulation of neuronal activity in rat substantia nigra. Synapse. 1998 Sep;30(1):18-29. doi: 10.1002/(SICI)1098-2396(199809)30:13.0.CO;2-N.
- Background Royall DR, Cordes JA, Polk M. CLOX: an executive clock drawing task. J Neurol Neurosurg Psychiatry. 1998 May;64(5):588-94. doi: 10.1136/jnnp.64.5.588.
- Background Diagnostic and Statistical Manual of Mental Disorders, Forth Edition, Text Revision. Washington D.C., American Psychiatric Association, 2000.
- Background Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Lawrence Erlbaum Associates, New Jersey.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Memantine | Unknown | 20 mg | — |