Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty

Delirium Clinical Trial

Official title:

Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04227873
• Other study ID #: HVH01
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Hvidovre University Hospital
• Contact: Alexandre Garioud, MD
• Phone: +4542705009
• Email: alexandre.garioud[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Delirium
• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (8)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Anders Troelsen, Henning Piilgaard Hansen, Henrik Kehlet, Kirill Gromov, Mette Grentoft, Nicolai Bang Foss, Poul Jenum

Country where clinical trial is conducted

Denmark, 

References & 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. Review. Erratum in: Eur J Anaesthesiol. 2018 Sep;35(9):718-719. — View Citation

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, Tenhage — View Citation

Gromov K, Kjærsgaard-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. — View Citation

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. — View Citation

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. — View Citation

Keats AS. The ASA classification of physical status--a recapitulation. Anesthesiology. 1978 Oct;49(4):233-6. — View Citation

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. — View Citation

Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. — View Citation

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. — View Citation

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. — View Citation

Krenk L, Rasmussen LS, Hansen TB, Bogø S, Søballe 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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, Kus — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective measurement of tiredness	questionnaire. Better sleep, better outcome.	One night 2 to 4 night preoperatively, and after the second postoperative night.
Other	Subjective measurement of sleep quality	Pittsburgh Sleep Quality Index. Lower score, better outcome.	One night 2 to 4 night preoperatively, and after the second postoperative night.
Other	Changes in preoperative inflammatory marker level (CRP) compared to postoperative.	Blod samples	One night 2 to 4 night preoperatively, and after the second postoperative night.
Other	Subjective measurements of pain at rest and after mobilisation.	questionnaire. Visual Analogue Scale(VAS). Lower score, better outcome.	Immediately after surgery, and after the first and second postoperative night.
Other	Registration of opioid use.	questionnaire. Less opioid use, better outcome.	Immediately after surgery, and after the first and second postoperative night.
Primary	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	Changes Remaining sleep stages and sleep variables (i.a. apnea)	Polysomnography	One night 2 to 4 night preoperatively, and the first and second postoperative night.
Secondary	Presence and severity of postoperative delirium compared to preoperative	Confusion Assessement Method-Severity (CAM-S). High scores, better outcome.	One night 2 to 4 night preoperatively, and after the second postoperative night.
Secondary	Presence and severity of postoperative cognitive impairment compared to preoperative	Mini Mental State Examination (MMSE), High scores, better outcome.	One night 2 to 4 night preoperatively, and after the second postoperative night.