Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in prevalence of rapid eye movement sleep
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in prevalence of rapid eye movement sleep
时间窗: Up to 36 hours
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).
次要结局
- Depth of anesthesia(At time of surgery)
- Hemodynamic parameters(At time of surgery)
- Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)(Up to 36 hours)
- Postoperative complications(Participants will be followed up for hospital stay an expected average of 7 days)
- Opioid requirements(Participants will be followed up for hospital stay an expected average of 7 days)
- Inflammation parameters(Participants will be followed up for hospital stay an expected average of 7 days)
- Insomnia Severity Index(Up to 90 days after the operation)
- Epsworth Sleepiness Scale(Up to 90 days after the operation)
- Postoperative Cognitive Dysfunction(Up to 90 days after the operation)
- 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)
- Changes in prevalence of rapid eye movement sleep(Up to 24 hours)
- Malnutrition(Up to 90 days after the operation)
- Length of hospital stay(Participants will be followed up for hospital stay an expected average of 7 days)
- Pain(Participants will be followed up for hospital stay an expected average of 7 days)
- N-Methyl-D-aspartate (NMDA)-receptor autologous antibodies(Up to 90 days after the operation)
- Severity of postoperative Delirium(Up to 36 hours)
研究者
Claudia Spies
Univ.-Prof. Dr. C. Spies
Charite University, Berlin, Germany