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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep Architecture

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).

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with elective hip surgery; Patients with elective hip surgery (implementation or replacement of hip joint endoprotheses).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	The ISI will be assessed by self-assessment questionnaire	Up to 90 days after the operation
Malnutrition	Malnutrition Screening Tools	Up to 90 days after the operation
Epsworth Sleepiness Scale	The ESS will be assessed by self-assessment questionnaire	Up to 90 days after the operation
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
Depth of anesthesia	Depth of anesthesia will be measured by processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®)	At time of surgery
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
Length of hospital stay		Participants will be followed up for hospital stay an expected average of 7 days
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
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
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
Hemodynamic parameters	Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor	At time of surgery
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
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
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
Postoperative complications	Including Severity of Delirium	Participants will be followed up for hospital stay an expected average of 7 days
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Inhibitor of Metalloproteinases	Metalloproteinases (MMP-2 und MMP-9) from liquor samples (only in patients with spinal anesthesia).	At time of spinal anesthesia
Metalloproteinases	Metalloproteinases (MMP-2 und MMP-9) from liquor samples (only in patients with spinal anesthesia).	At time of spinal anesthesia
ASA (physical status classification system) status		At the beginning of the investigation
Benzodiazepine premedication		At the beginning of the investigation

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: TepSo