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

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Sleep Architecture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with elective hip surgery

Patients with elective hip surgery (implementation or replacement of hip joint endoprotheses).

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No