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

Sleep Architecture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02302560
• Other study ID #: TepSo
• Status: Withdrawn
• First received: November 7, 2014
• Last updated: April 17, 2018
• Start date: February 2015
• Est. completion date: November 2019

Study information

• Verified date: April 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Architecture

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tissue Inhibitor of Metalloproteinases	Metalloproteinases (MMP-2 und MMP-9) from liquor samples (only in patients with spinal anesthesia).	At time of spinal anesthesia
Other	Metalloproteinases	Metalloproteinases (MMP-2 und MMP-9) from liquor samples (only in patients with spinal anesthesia).	At time of spinal anesthesia
Other	ASA (physical status classification system) status		At the beginning of the investigation
Other	Benzodiazepine premedication		At the beginning of the investigation
Primary	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	Insomnia Severity Index	The ISI will be assessed by self-assessment questionnaire	Up to 90 days after the operation
Secondary	Malnutrition	Malnutrition Screening Tools	Up to 90 days after the operation
Secondary	Epsworth Sleepiness Scale	The ESS will be assessed by self-assessment questionnaire	Up to 90 days after the operation
Secondary	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
Secondary	Depth of anesthesia	Depth of anesthesia will be measured by processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®)	At time of surgery
Secondary	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
Secondary	Length of hospital stay		Participants will be followed up for hospital stay an expected average of 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Hemodynamic parameters	Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor	At time of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative complications	Including Severity of Delirium	Participants will be followed up for hospital stay an expected average of 7 days
Secondary	Transfusion requirements		Participants will be followed up for hospital stay an expected average of 7 days
Secondary	Catecholamine administration intra- und postoperative		Participants will be followed up for hospital stay an expected average of 7 days
Secondary	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