Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively.

Detailed Description
-----------------
Sleep research has confirmed the association of sleep (REM sleep and slow-wave sleep) with memory and cognitive function in general. There are changes in the quantity of REM sleep after certain forms of anesthesia, especially with barbiturate, as shown in mouse model. This study is designed to be the first explorative clinical studyl to measure changes in sleep architecture in surgical patients undergoing different types of anesthesia (general anesthesia and spinal anesthesia) and its potential associations with the development of postoperative delirium and postoperative cognitive dysfunction. Additionally, parameters will be collected, that from recent research are suspected to be reliable markers for systemic inflammation that might account for delirium and cognitive dysfunction after surgical interventions. Patients were stratified into two groups: age (≤ 65 years; > 65 years) and benzodiazepine premedication (yes/no).

Official Title
-----------------
Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)

Conditions
-----------------
Sleep Architecture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with age 50 years and above Intervention for hip joint endoprosthesis or replacement of endoprosthesis at the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum, Charité - University Medicine Berlin Exclusion Criteria: Lacking willingness to save and hand out data within the study Missing informed consent of the patient Participation in other prospective interventional study 10 days before study inclusion and during the study period Patients with diagnosed and treated sleep disorders Patients with psychiatric diseases Patients with injuries or operations of the enteral tract and the esophagus respectively in the last four weeks before the hip surgery Allergies to any substance of the electrode fixing material Dermatoses in the area of the electrodes to be fixed

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with elective hip surgery<br>Patients with elective hip surgery (implementation or replacement of hip joint endoprotheses). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in prevalence of rapid eye movement sleep | Changes in prevalence of rapid eye movement (REM) sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day). | Up to 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | The ISI will be assessed by self-assessment questionnaire | Up to 90 days after the operation | 
| Malnutrition | Malnutrition Screening Tools | Up to 90 days after the operation | 
| Epsworth Sleepiness Scale | The ESS will be assessed by self-assessment questionnaire | Up to 90 days after the operation | 
| Postoperative Cognitive Dysfunction | Postoperative Cognitive Dysfunction will be measured at hospital discharge and at the 90th postoperative day. | Up to 90 days after the operation | 
| Depth of anesthesia | Depth of anesthesia will be measured by processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®) | At time of surgery | 
| Opioid requirements | Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI) | Participants will be followed up for hospital stay an expected average of 7 days | 
| Length of hospital stay |  | Participants will be followed up for hospital stay an expected average of 7 days | 
| Pain | Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI) | Participants will be followed up for hospital stay an expected average of 7 days | 
| N-Methyl-D-aspartate (NMDA)-receptor autologous antibodies | Identification of NMDA-receptor autologous antibodies in blood serum and cerebrospinal fluid; the requested blood samples will be collected on the operation day, on the last day of hospitalisation and after 90 days. The requested liquor samples will be collected on the operation day (only in patients with spinal anesthesia). | Up to 90 days after the operation | 
| Inflammation parameters | Assessment of inflammation parameters by means of extended differential blood count (Sysmex) ; the requested blood samples will be collected on the preoperative day, on the day of the intervention, on the following day and on the last day of the hospitalisation | Participants will be followed up for hospital stay an expected average of 7 days | 
| Hemodynamic parameters | Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor | At time of surgery | 
| Changes in prevalence of rapid eye movement sleep | REM-Sleep at operation day/night in comparison to preoperative night. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 24 h. | Up to 24 hours | 
| Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep) | Slow wave sleep at operation day/night in comparison to preoperative night. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 24 h. | Up to 24 hours | 
| Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep) | Changes in prevalence of slow-wave sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day). | Up to 36 hours | 
| Postoperative complications | Including Severity of Delirium | Participants will be followed up for hospital stay an expected average of 7 days | 
| Transfusion requirements |  | Participants will be followed up for hospital stay an expected average of 7 days | 
| Catecholamine administration intra- und postoperative |  | Participants will be followed up for hospital stay an expected average of 7 days | 
| Severity of postoperative Delirium | Delirium screening will be conducted preoperatively, one hour postoperative, the evening of operation day, and the following morning with the scoring devices of confusion assessment method (CAM), by confusion assessment method in the intensive care unit (CAM-ICU) or by Nursing Delirium Screening Scale (Nu-DESC) | Up to 36 hours |