Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty

NCT04227873 | Unknown DMC

• 1 other identifier: HVH01
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep and rest are key elements in postoperative rehabilitation and recovery. There are complex relations between major surgery, sleep disturbance and complications. Major surgery leeds to severe postoperative sleep disturbances, initially reducing REM sleep time and disturbing the remaining sleep stages. Major surgery is again a risk factor for postoperative delirium and other cognitive impairment. The underlying mechanisms includes pain, opioid medication, sleep disturbances and neuroinflammation, along with external factors as noise during hospitalisation. The physiologic stress from sleep disturbances and sleep deprivation is associated with blood-brain barrier impairment, inflammation, decreased restitution, altered nociceptive function. Likewise, undiagnosed and untreated sleep apnea is a risk for postoperative complications and is itself affected by anesthesia and some analgesics (i.a. opioids). 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.

Conditions

Sleep Disturbance; Delirium; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• Changes in postoperative REM sleep time compared to preoperative

  Polysomnography

  One night 2 to 4 night preoperatively, and the first and second postoperative night.

Secondary Outcomes (3)

• Changes Remaining sleep stages and sleep variables (i.a. apnea)

  One night 2 to 4 night preoperatively, and the first and second postoperative night.

• Presence and severity of postoperative delirium compared to preoperative

  One night 2 to 4 night preoperatively, and after the second postoperative night.

• Presence and severity of postoperative cognitive impairment compared to preoperative

  One night 2 to 4 night preoperatively, and after the second postoperative night.

Other Outcomes (5)

• Subjective measurement of tiredness

  One night 2 to 4 night preoperatively, and after the second postoperative night.

• Subjective measurement of sleep quality

  One night 2 to 4 night preoperatively, and after the second postoperative night.

• Changes in preoperative inflammatory marker level (CRP) compared to postoperative.

  One night 2 to 4 night preoperatively, and after the second postoperative night.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

16 adult attending scheduled hip or knee arthroplasty in an ambulatory fast-track setting with spinal anesthesia corresponding to the above mentioned inclusion criteria.

You may qualify if:

• ASA classification I or II
• 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

You may not qualify if:

• Hospital discharge later than same day after surgery
• No consent form patient
• Alcohol or drug abuse
• Anxiolytic og antipsychotic treatment
• Preoperative opioid treatment
• Soporific treatment

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Kehlet, Henrik, M.D., Ph.D.: collaborator
• Nicolai Bang Foss: collaborator
• Poul Jenum: collaborator
• Anders Troelsen: collaborator
• Kirill Gromov: collaborator
• Mette Grentoft: collaborator
• Henning Piilgaard Hansen: collaborator

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (16)

• 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.

  PMID: 28187050 BACKGROUND

• 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.

  PMID: 24733193 BACKGROUND

• 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.

  PMID: 697075 BACKGROUND

• 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.

  PMID: 20626359 RESULT

• 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.

  PMID: 24634631 RESULT

• 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.

  PMID: 22831887 RESULT

• 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.

  PMID: 24300462 RESULT

• 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.

  PMID: 31011286 RESULT

• 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.

  PMID: 25355222 RESULT

• 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.

  PMID: 30169703 RESULT

• 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.

  PMID: 28666588 RESULT

• 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.

  PMID: 23663938 RESULT

• 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.

  PMID: 29781366 RESULT

• 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.

  PMID: 22277666 RESULT

• 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.

  PMID: 28426262 RESULT

• 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.

  PMID: 30523329 RESULT

MeSH Terms

Conditions

Parasomnias; Delirium

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Henrik Kehlet, Dr.med,Phd

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Central Study Contacts

Alexandre Garioud, MD

CONTACT

+4542705009; alexandre.garioud@gmail.com

Henrik Kehlet, Dr.med,Phd

CONTACT

+ 45 3545 4774; henrik.kehlet@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: January 14, 2020
• Study Start: March 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)