Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium
NCT ID: NCT02928692
Last Updated: 2020-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
750 participants
INTERVENTIONAL
2016-11-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo administered before surgery
Placebo
Minocycline
Minocycline was administrated before surgery
Minocycline
Volunteers
Health people for calculate the incidence of POCD
No interventions assigned to this group
Interventions
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Minocycline
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Speak Chinese Mandarin
3. Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to III
1. Elder than 65 years old
2. Speak Chinese Mandarin
3. Signed the inform consent
4. No major disease health people
Exclusion Criteria
2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
3. Severe audition or vision disorder;
4. Unwillingness to comply with the protocol or procedures.
5. Cannot communicated with Chinese Mandarin
6. With severe skin disease
7. Serious heart or liver or renal insufficiency patients
8. Had surgery in the past 30 days
9. Allergy to tetracycline or minocycline
For the health volunteers;
1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
3. Severe audition or vision disorder;
4. Unwillingness to comply with the protocol or procedures.
5. Cannot communicated with Chinese Mandarin
6. Drug abuse, alcoholism
7. Serious heart or liver or renal insufficiency patients
8. Had surgery in the past 30 days
9. Plan to undergo surgery in the following 3 months.
65 Years
ALL
Yes
Sponsors
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Shanghai 10th People's Hospital
OTHER
Pudong New Area People's Hospital
UNKNOWN
Shanghai Pudong Hospital
OTHER
Shanghai Pudong New Aera Dongming Community Health Care Center
UNKNOWN
RenJi Hospital
OTHER
Responsible Party
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diansan su
Dr.
Locations
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Scales
Shanghai, Shanghai Municipality, China
Shanghai Pudong Hospital
Shanghai, , China
Shanghai Pudong New Area Dongming Community Health Care Center
Shanghai, , China
Shanghai Pudong New Area people's Hopsital
Shanghai, , China
Shanghai Tenth Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Hongwei Duan
Role: primary
Shifen Zhang
Role: primary
References
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Large MC, Reichard C, Williams JT, Chang C, Prasad S, Leung Y, DuBeau C, Bales GT, Steinberg GD. Incidence, risk factors, and complications of postoperative delirium in elderly patients undergoing radical cystectomy. Urology. 2013 Jan;81(1):123-8. doi: 10.1016/j.urology.2012.07.086. Epub 2012 Nov 13.
Pol RA, van Leeuwen BL, Izaks GJ, Reijnen MM, Visser L, Tielliu IF, Zeebregts CJ. C-reactive protein predicts postoperative delirium following vascular surgery. Ann Vasc Surg. 2014 Nov;28(8):1923-30. doi: 10.1016/j.avsg.2014.07.004. Epub 2014 Jul 10.
Nadelson MR, Sanders RD, Avidan MS. Perioperative cognitive trajectory in adults. Br J Anaesth. 2014 Mar;112(3):440-51. doi: 10.1093/bja/aet420. Epub 2014 Jan 2.
Westhoff D, Witlox J, Koenderman L, Kalisvaart KJ, de Jonghe JF, van Stijn MF, Houdijk AP, Hoogland IC, Maclullich AM, van Westerloo DJ, van de Beek D, Eikelenboom P, van Gool WA. Preoperative cerebrospinal fluid cytokine levels and the risk of postoperative delirium in elderly hip fracture patients. J Neuroinflammation. 2013 Oct 7;10:122. doi: 10.1186/1742-2094-10-122.
Shim JJ, Leung JM. An update on delirium in the postoperative setting: prevention, diagnosis and management. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):327-43. doi: 10.1016/j.bpa.2012.08.003.
van Meenen LC, van Meenen DM, de Rooij SE, ter Riet G. Risk prediction models for postoperative delirium: a systematic review and meta-analysis. J Am Geriatr Soc. 2014 Dec;62(12):2383-90. doi: 10.1111/jgs.13138.
American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
Bellelli G, Mazzola P, Morandi A, Bruni A, Carnevali L, Corsi M, Zatti G, Zambon A, Corrao G, Olofsson B, Gustafson Y, Annoni G. Duration of postoperative delirium is an independent predictor of 6-month mortality in older adults after hip fracture. J Am Geriatr Soc. 2014 Jul;62(7):1335-40. doi: 10.1111/jgs.12885. Epub 2014 Jun 2.
Ramaiah R, Lam AM. Postoperative cognitive dysfunction in the elderly. Anesthesiol Clin. 2009 Sep;27(3):485-96, table of contents. doi: 10.1016/j.anclin.2009.07.011.
Sauer AM, Kalkman C, van Dijk D. Postoperative cognitive decline. J Anesth. 2009;23(2):256-9. doi: 10.1007/s00540-009-0744-5. Epub 2009 May 15.
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.
Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
Vacas S, Degos V, Feng X, Maze M. The neuroinflammatory response of postoperative cognitive decline. Br Med Bull. 2013;106(1):161-78. doi: 10.1093/bmb/ldt006. Epub 2013 Apr 4.
Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. doi: 10.1097/00000542-200703000-00007.
Fidalgo AR, Cibelli M, White JP, Nagy I, Maze M, Ma D. Systemic inflammation enhances surgery-induced cognitive dysfunction in mice. Neurosci Lett. 2011 Jul 1;498(1):63-6. doi: 10.1016/j.neulet.2011.04.063. Epub 2011 May 6.
Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.
Terrando N, Eriksson LI, Ryu JK, Yang T, Monaco C, Feldmann M, Jonsson Fagerlund M, Charo IF, Akassoglou K, Maze M. Resolving postoperative neuroinflammation and cognitive decline. Ann Neurol. 2011 Dec;70(6):986-995. doi: 10.1002/ana.22664.
Vacas S, Degos V, Tracey KJ, Maze M. High-mobility group box 1 protein initiates postoperative cognitive decline by engaging bone marrow-derived macrophages. Anesthesiology. 2014 May;120(5):1160-7. doi: 10.1097/ALN.0000000000000045.
Wan Y, Xu J, Meng F, Bao Y, Ge Y, Lobo N, Vizcaychipi MP, Zhang D, Gentleman SM, Maze M, Ma D. Cognitive decline following major surgery is associated with gliosis, beta-amyloid accumulation, and tau phosphorylation in old mice. Crit Care Med. 2010 Nov;38(11):2190-8. doi: 10.1097/CCM.0b013e3181f17bcb.
Su X, Feng X, Terrando N, Yan Y, Chawla A, Koch LG, Britton SL, Matthay MA, Maze M. Dysfunction of inflammation-resolving pathways is associated with exaggerated postoperative cognitive decline in a rat model of the metabolic syndrome. Mol Med. 2013 Feb 8;18(1):1481-90. doi: 10.2119/molmed.2012.00351.
Other Identifiers
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20158202
Identifier Type: -
Identifier Source: org_study_id
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