Clinical trial NCT04488952: The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly
Official title: The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PND
Keywords: PND,anesthesia method, elderly
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 350
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the elderly, especially in the plastic surgery. Different anesthesia methods have different incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve block combined with general anesthesia. We will apply a psychometric battery test which contain different cognitive domains to estimate the incidence of PND at a week a month and a year after surgery with different anesthesia methods. Study has showed that functional magnetic resonance imaging (fMRI) could detect a cognitive decline through spontaneous neuronal activity in the cortex and hippocampus. In our study, multi-mode imaging technology is used to conduct in-depth research on MRI and make correlation analysis with cognitive function.


Eligibility criteria: Inclusion Criteria:

* aged 60-85years
* ASA I-III
* Received elective surgery of unilateral lower extremity orthopedics
* The anesthesia lasted more than 2 hours

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of PND seven days after surgery
timeFrame: seven days after surgery
Secondary outcomes:
measure: Incidence of PND one month after surgery
timeFrame: one month after surgery
measure: Incidence of PND one year after surgery
timeFrame: one year after surgery
measure: Hospital stay
timeFrame: one to two weeks after surgery
measure: Number of patients entrance the ward of ICU after surgery
timeFrame: one week post-operation
measure: Mortality rate
timeFrame: one year after surgery
measure: Postoperative complications
timeFrame: one month post-operation
measure: ADL of frontal lobe，temporal lobe and occipital lobe
timeFrame: one day pre-operation, one week post-operation
measure: ADL of frontal lobe
timeFrame: one day pre-operation, one week post-operation
measure: BOLD of the whole brain
timeFrame: one day pre-operation, one week post-operation
measure: ADL of temporal lobe
timeFrame: one day pre-operation, one week post-operation
measure: ADL of occipital lobe
timeFrame: one day pre-operation, one week post-operation
measure: One year event-free survival
timeFrame: one year after surgery
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
References:
citation: Bittner EA, Yue Y, Xie Z. Brief review: anesthetic neurotoxicity in the elderly, cognitive dysfunction and Alzheimer's disease. Can J Anaesth. 2011 Feb;58(2):216-23. doi: 10.1007/s12630-010-9418-x. Epub 2010 Dec 21.
citation: Yildizeli B, Ozyurtkan MO, Batirel HF, Kuscu K, Bekiroglu N, Yuksel M. Factors associated with postoperative delirium after thoracic surgery. Ann Thorac Surg. 2005 Mar;79(3):1004-9. doi: 10.1016/j.athoracsur.2004.06.022.
citation: Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.
citation: Alkire MT, Pomfrett CJ, Haier RJ, Gianzero MV, Chan CM, Jacobsen BP, Fallon JH. Functional brain imaging during anesthesia in humans: effects of halothane on global and regional cerebral glucose metabolism. Anesthesiology. 1999 Mar;90(3):701-9. doi: 10.1097/00000542-199903000-00011.
citation: Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.
citation: Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.
citation: Squire LR. Memory and the hippocampus: a synthesis from findings with rats, monkeys, and humans. Psychol Rev. 1992 Apr;99(2):195-231. doi: 10.1037/0033-295x.99.2.195.
citation: Zola-Morgan S, Squire LR, Amaral DG. Human amnesia and the medial temporal region: enduring memory impairment following a bilateral lesion limited to field CA1 of the hippocampus. J Neurosci. 1986 Oct;6(10):2950-67. doi: 10.1523/JNEUROSCI.06-10-02950.1986.
citation: Price CC, Tanner JJ, Schmalfuss I, Garvan CW, Gearen P, Dickey D, Heilman K, McDonagh DL, Libon DJ, Leonard C, Bowers D, Monk TG. A pilot study evaluating presurgery neuroanatomical biomarkers for postoperative cognitive decline after total knee arthroplasty in older adults. Anesthesiology. 2014 Mar;120(3):601-13. doi: 10.1097/ALN.0000000000000080.
citation: Hole A, Terjesen T, Breivik H. Epidural versus general anaesthesia for total hip arthroplasty in elderly patients. Acta Anaesthesiol Scand. 1980 Aug;24(4):279-87. doi: 10.1111/j.1399-6576.1980.tb01549.x.
citation: 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.
citation: Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
citation: Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
citation: Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.
citation: O'Hara DA, Duff A, Berlin JA, Poses RM, Lawrence VA, Huber EC, Noveck H, Strom BL, Carson JL. The effect of anesthetic technique on postoperative outcomes in hip fracture repair. Anesthesiology. 2000 Apr;92(4):947-57. doi: 10.1097/00000542-200004000-00011.
citation: Chen MH, Liao Y, Rong PF, Hu R, Lin GX, Ouyang W. Hippocampal volume reduction in elderly patients at risk for postoperative cognitive dysfunction. J Anesth. 2013 Aug;27(4):487-92. doi: 10.1007/s00540-012-1548-6. Epub 2013 Jan 31.
citation: Maekawa K, Baba T, Otomo S, Morishita S, Tamura N. Low pre-existing gray matter volume in the medial temporal lobe and white matter lesions are associated with postoperative cognitive dysfunction after cardiac surgery. PLoS One. 2014 Jan 27;9(1):e87375. doi: 10.1371/journal.pone.0087375. eCollection 2014.
citation: Wei M, Shi J, Li T, Ni J, Zhang X, Li Y, Kang S, Ma F, Xie H, Qin B, Fan D, Zhang L, Wang Y, Tian J. Diagnostic Accuracy of the Chinese Version of the Trail-Making Test for Screening Cognitive Impairment. J Am Geriatr Soc. 2018 Jan;66(1):92-99. doi: 10.1111/jgs.15135. Epub 2017 Nov 14.
citation: Ruff RM, Light RH, Parker SB, Levin HS. The psychological construct of word fluency. Brain Lang. 1997 May;57(3):394-405. doi: 10.1006/brln.1997.1755.
citation: Shi J, Tian J, Wei M, Miao Y, Wang Y. The utility of the Hopkins Verbal Learning Test (Chinese version) for screening dementia and mild cognitive impairment in a Chinese population. BMC Neurol. 2012 Nov 7;12:136. doi: 10.1186/1471-2377-12-136.
citation: Norkiene I, Samalavicius R, Ivaskevicius J, Budrys V, Paulauskiene K. Asymptomatic carotid artery stenosis and cognitive outcomes after coronary artery bypass grafting. Scand Cardiovasc J. 2011 Jun;45(3):169-73. doi: 10.3109/14017431.2011.562525. Epub 2011 Mar 15.
citation: Knopman DS, Roberts RO, Geda YE, Pankratz VS, Christianson TJ, Petersen RC, Rocca WA. Validation of the telephone interview for cognitive status-modified in subjects with normal cognition, mild cognitive impairment, or dementia. Neuroepidemiology. 2010;34(1):34-42. doi: 10.1159/000255464. Epub 2009 Nov 5.
citation: Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
citation: Li WX, Luo RY, Chen C, Li X, Ao JS, Liu Y, Yin YQ. Effects of propofol, dexmedetomidine, and midazolam on postoperative cognitive dysfunction in elderly patients: a randomized controlled preliminary trial. Chin Med J (Engl). 2019 Feb;132(4):437-445. doi: 10.1097/CM9.0000000000000098.