Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty
- Conditions
- Sleep DisturbanceArthroplasty ComplicationsDelirium
- Registration Number
- NCT04227873
- Lead Sponsor
- Hvidovre University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in postoperative REM sleep time compared to preoperative One night 2 to 4 night preoperatively, and the first and second postoperative night. Polysomnography
- Secondary Outcome Measures
Name Time Method Presence and severity of postoperative delirium compared to preoperative One night 2 to 4 night preoperatively, and after the second postoperative night. Confusion Assessement Method-Severity (CAM-S). High scores, better outcome.
Presence and severity of postoperative cognitive impairment compared to preoperative One night 2 to 4 night preoperatively, and after the second postoperative night. Mini Mental State Examination (MMSE), High scores, better outcome.
Changes Remaining sleep stages and sleep variables (i.a. apnea) One night 2 to 4 night preoperatively, and the first and second postoperative night. Polysomnography
Trial Locations
- Locations (1)
Hvidovre Hospital
🇩🇰Hvidovre, Denmark