Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty
NCT ID: NCT04227873
Last Updated: 2020-02-18
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
16 participants
OBSERVATIONAL
2020-03-31
2020-07-31
Brief Summary
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Fast-track surgery development has led to restitution period shortening, optimized pain management reducing opioid use, postoperative inflammatory stress response reduction and less delirium. Evolution of hip and knee arthroplasty(THA/TKA), organisation, optimized pain management and pharmacologic modification of inflammatory response by high dose steroid has permitted to perform these surgeries in an outpatient setting.
Previous studies of fast-track THA/TKA using multimodal opioid-sparring analgesia, however neither using high dose steroids nor in an out patient setting, have demonstrated REM sleep period reduction from a normal range of 18% preoperatively to 1% postoperatively. However, changes in sleep architecture after THA/TKA in at setting attempting to minimise abnormal sleep by means of ambulatory surgery added to perioperative reduction of inflammatory response to surgery, pain and opioid use by high dose steroid, haven't been studied.
The purpose of this study is to investigate how much an optimized ambulatory THA/TKA , reducing pain and inflammatory response to surgery and opioid use by high doses steroid can conserve the preoperative sleep architecture.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Scheduled hospital discharge same day after surgery
* Adult person following the patient 24 hours at the patients habitation
* Informed consent and signature.
* Patient speaks and understands Danish
Exclusion Criteria
* No consent form patient
* Alcohol or drug abuse
* Anxiolytic og antipsychotic treatment
* Preoperative opioid treatment
* Soporific treatment
18 Years
80 Years
ALL
No
Sponsors
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Kehlet, Henrik, M.D., Ph.D.
INDIV
Nicolai Bang Foss
UNKNOWN
Poul Jenum
UNKNOWN
Anders Troelsen
UNKNOWN
Kirill Gromov
UNKNOWN
Mette Grentoft
UNKNOWN
Henning Piilgaard Hansen
UNKNOWN
Hvidovre University Hospital
OTHER
Responsible Party
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Alexandre Garioud
Principal investigator
Principal Investigators
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Henrik Kehlet, Dr.med,Phd
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
Inouye SK, Kosar CM, Tommet D, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Jones RN. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014 Apr 15;160(8):526-533. doi: 10.7326/M13-1927.
Keats AS. The ASA classification of physical status--a recapitulation. Anesthesiology. 1978 Oct;49(4):233-6. doi: 10.1097/00000542-197810000-00001. No abstract available.
Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12.
Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.
Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.
Riedel B, Browne K, Silbert B. Cerebral protection: inflammation, endothelial dysfunction, and postoperative cognitive dysfunction. Curr Opin Anaesthesiol. 2014 Feb;27(1):89-97. doi: 10.1097/ACO.0000000000000032.
Ni P, Dong H, Zhou Q, Wang Y, Sun M, Qian Y, Sun J. Preoperative Sleep Disturbance Exaggerates Surgery-Induced Neuroinflammation and Neuronal Damage in Aged Mice. Mediators Inflamm. 2019 Mar 18;2019:8301725. doi: 10.1155/2019/8301725. eCollection 2019.
He J, Hsuchou H, He Y, Kastin AJ, Wang Y, Pan W. Sleep restriction impairs blood-brain barrier function. J Neurosci. 2014 Oct 29;34(44):14697-706. doi: 10.1523/JNEUROSCI.2111-14.2014.
McMahon WR, Ftouni S, Drummond SPA, Maruff P, Lockley SW, Rajaratnam SMW, Anderson C. The wake maintenance zone shows task dependent changes in cognitive function following one night without sleep. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy148.
de Raaff CAL, Gorter-Stam MAW, de Vries N, Sinha AC, Jaap Bonjer H, Chung F, Coblijn UK, Dahan A, van den Helder RS, Hilgevoord AAJ, Hillman DR, Margarson MP, Mattar SG, Mulier JP, Ravesloot MJL, Reiber BMM, van Rijswijk AS, Singh PM, Steenhuis R, Tenhagen M, Vanderveken OM, Verbraecken J, White DP, van der Wielen N, van Wagensveld BA. Perioperative management of obstructive sleep apnea in bariatric surgery: a consensus guideline. Surg Obes Relat Dis. 2017 Jul;13(7):1095-1109. doi: 10.1016/j.soard.2017.03.022. Epub 2017 Mar 30.
Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available.
Kehlet H, Lindberg-Larsen V. High-dose glucocorticoid before hip and knee arthroplasty: To use or not to use-that's the question. Acta Orthop. 2018 Oct;89(5):477-479. doi: 10.1080/17453674.2018.1475177. Epub 2018 May 21. No abstract available.
Krenk L, Rasmussen LS, Hansen TB, Bogo S, Soballe K, Kehlet H. Delirium after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Apr;108(4):607-11. doi: 10.1093/bja/aer493. Epub 2012 Jan 24.
Gromov K, Kjaersgaard-Andersen P, Revald P, Kehlet H, Husted H. Feasibility of outpatient total hip and knee arthroplasty in unselected patients. Acta Orthop. 2017 Oct;88(5):516-521. doi: 10.1080/17453674.2017.1314158. Epub 2017 Apr 20.
Stephansen JB, Olesen AN, Olsen M, Ambati A, Leary EB, Moore HE, Carrillo O, Lin L, Han F, Yan H, Sun YL, Dauvilliers Y, Scholz S, Barateau L, Hogl B, Stefani A, Hong SC, Kim TW, Pizza F, Plazzi G, Vandi S, Antelmi E, Perrin D, Kuna ST, Schweitzer PK, Kushida C, Peppard PE, Sorensen HBD, Jennum P, Mignot E. Neural network analysis of sleep stages enables efficient diagnosis of narcolepsy. Nat Commun. 2018 Dec 6;9(1):5229. doi: 10.1038/s41467-018-07229-3.
Other Identifiers
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HVH01
Identifier Type: -
Identifier Source: org_study_id
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