Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 3:19 AM
Study NCT ID:
NCT03879850
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
Official Title:
Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators aim to identify preoperative Electroencephalogram (EEG) markers indicating patients at risk to develop postoperative delirium (POD), so that the anesthetist may adjust medications and dosages in order to avoid POD. Second, the investigators aim to specify intraoperative EEG signatures and EEG states that are related to POD and long-term cognitive dysfunction, again to enable physicians to adapt their procedure. Third, the investigators aim to identify EEG signatures during stay in the recovery room that is directly related to POD, and may therefore be used as diagnostic tool, as well as a predictor for the development of long-term cognitive deficits (POCD).
Detailed Description:
The investigators conduct this observational study to identify pre-, intra- and postoperative Electroencephalogram (EEG) signatures / intraoperative EEG states related to postoperative delirium (POD) and postoperative cognitive deficit (POCD) in elderly patients \> 70 years. This includes the following tasks at five different time-points
1. Pre-operative frontal EEG recording during anesthesia evaluation one day before surgery / anesthesia to develop an EEG marker to predict the development of POD. This includes the stratification of EEG data related to age, gender, and pre-operative cognitive function. Pre-operative POCD assessment (CANTAB connect, word pair recognition test, Mini Mental State Test, and Trail Making Test A and B) to classify cognitive capacity of each patient before start of anesthesia.
2. Intra-operative frontal EEG recording from start of anesthesia procedure until discharge to the recovery room to identify EEG signatures / EEG states to predict the development of POD / POCD. This includes the stratification of EEG data related to age, gender, pre-medication, anesthetics, and analgesics used during anesthesia procedure.
3. Post-operative frontal EEG recording during the recovery room stay to develop an EEG marker / identify EEG signatures to diagnose POD and predict POCD. This includes the stratification of EEG data related to age, gender, anesthesia procedure, and analgesics administered during the recovery room stay. POD will be assessed during stay in the recovery room by the NuDesc Score and DSM V criteria.
4. Follow-up POD assessments until the 5th postoperative day, where the patient will be visited twice daily (8a.m.-10a.m. and 5p.m.-7p.m.) and assessed via DSM V / NuDesc criteria on the peripheral ward, or via Confusion Assessment Method for intensive Care Unit (CAM-ICU) criteria during an intensive care unit stay.
5. Follow-up POCD assessments one day before and 3 months after surgery, where the patient will undergo a \~1 hour cognitive testing with the CANTAB connect.
1. Pre-operative frontal EEG recording during anesthesia evaluation one day before surgery / anesthesia to develop an EEG marker to predict the development of POD. This includes the stratification of EEG data related to age, gender, and pre-operative cognitive function. Pre-operative POCD assessment (CANTAB connect, word pair recognition test, Mini Mental State Test, and Trail Making Test A and B) to classify cognitive capacity of each patient before start of anesthesia.
2. Intra-operative frontal EEG recording from start of anesthesia procedure until discharge to the recovery room to identify EEG signatures / EEG states to predict the development of POD / POCD. This includes the stratification of EEG data related to age, gender, pre-medication, anesthetics, and analgesics used during anesthesia procedure.
3. Post-operative frontal EEG recording during the recovery room stay to develop an EEG marker / identify EEG signatures to diagnose POD and predict POCD. This includes the stratification of EEG data related to age, gender, anesthesia procedure, and analgesics administered during the recovery room stay. POD will be assessed during stay in the recovery room by the NuDesc Score and DSM V criteria.
4. Follow-up POD assessments until the 5th postoperative day, where the patient will be visited twice daily (8a.m.-10a.m. and 5p.m.-7p.m.) and assessed via DSM V / NuDesc criteria on the peripheral ward, or via Confusion Assessment Method for intensive Care Unit (CAM-ICU) criteria during an intensive care unit stay.
5. Follow-up POCD assessments one day before and 3 months after surgery, where the patient will undergo a \~1 hour cognitive testing with the CANTAB connect.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: