NCT02302560

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sleep Architecture

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-02-01
• Completion: 2019-11-01
• First posted: 2014-11-27
• Last updated: 2018-04-18

Locations

1 site across 1 country: Germany