Clinical trial NCT02302560: Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)
Official title: Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Architecture
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with elective hip surgery (implementation or replacement of hip joint endoprothesis)

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).

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

Primary outcomes:
measure: Changes in prevalence of rapid eye movement sleep
timeFrame: Up to 36 hours
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: Up to 90 days after the operation
measure: Malnutrition
timeFrame: Up to 90 days after the operation
measure: Epsworth Sleepiness Scale
timeFrame: Up to 90 days after the operation
measure: Postoperative Cognitive Dysfunction
timeFrame: Up to 90 days after the operation
measure: Depth of anesthesia
timeFrame: At time of surgery
measure: Opioid requirements
timeFrame: Participants will be followed up for hospital stay an expected average of 7 days
measure: Length of hospital stay
timeFrame: Participants will be followed up for hospital stay an expected average of 7 days
measure: Pain
timeFrame: Participants will be followed up for hospital stay an expected average of 7 days
measure: N-Methyl-D-aspartate (NMDA)-receptor autologous antibodies
timeFrame: Up to 90 days after the operation
measure: Inflammation parameters
timeFrame: Participants will be followed up for hospital stay an expected average of 7 days
measure: Hemodynamic parameters
timeFrame: At time of surgery
measure: Changes in prevalence of rapid eye movement sleep
timeFrame: Up to 24 hours
measure: Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)
timeFrame: Up to 24 hours
measure: Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)
timeFrame: Up to 36 hours
measure: Postoperative complications
timeFrame: Participants will be followed up for hospital stay an expected average of 7 days
measure: Transfusion requirements
timeFrame: Participants will be followed up for hospital stay an expected average of 7 days
measure: Catecholamine administration intra- und postoperative
timeFrame: Participants will be followed up for hospital stay an expected average of 7 days
measure: Severity of postoperative Delirium
timeFrame: Up to 36 hours
Other outcomes:
measure: Tissue Inhibitor of Metalloproteinases
timeFrame: At time of spinal anesthesia
measure: Metalloproteinases
timeFrame: At time of spinal anesthesia
measure: ASA (physical status classification system) status
timeFrame: At the beginning of the investigation
measure: Benzodiazepine premedication
timeFrame: At the beginning of the investigation
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: