Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly

Postoperative Delirium Clinical Trial

Official title:

Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879850
• Other study ID #: EPOD
• Status: Completed
• Start date: March 19, 2019
• Est. completion date: November 28, 2022

Study information

• Verified date: March 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: November 28, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Patients aged >70 years

• Planned operation time >1 hour

• Expected hospital treatment period of 5 days,

• Anesthesia induction, anesthesia maintenance with either Propofol or an inhalative anesthetic agent as Sevoflurane or Desflurane,

• The ability to give informed consent

Exclusion Criteria:

• Patients with a history of neurological or psychiatric disorders

• Known carotid artery Stenosis

• Obstructive sleep apnea Syndrome

• Planned neurosurgery

• Current medication of tranquilizers / antidepressants

• Isolation of patients with multi-resistant Bacteria

• Inability of the patients to speak and/or read German

• Homelessness or other circumstances where the patient would not be reachable by phone or postal services during follow-up

• Intraoperative EEG data file analysis will be excluded ex post,

1. when intraoperative use of any other anesthetic agent for induction as Propofol occurred or

2. by use of any other anesthetic agent for anesthesia maintenance other than Propofol or volatile anesthetics as Sevoflurane or Desflurane or

3. when anesthesia agents as Ketamine, Nitrous oxide, Etomidate or Dexmedetomidine were given or

4. if body temperature drops below 34° or rises above 38° during surgery

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutsche Forschung (Projekt No 409495393)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative Delirium- Diagnostic and Statistical Manual of Mental Disorders (DSM-V)	Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)	Patients will be follow until hospital discharge, or maximal until postoperative day 5
Primary	Incidence of Postoperative Delirium - Nursing Delrium Scale (Nu-DESC)	Postoperative delirium rate, defined according to = 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC)	Patients will be follow until hospital discharge, or maximal until postoperative day 5
Primary	Incidence of Postoperative Delirium - Intensive Care Unit (CAM-ICU)	Postoperative delirium rate, defined according to positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score	Patients will be followed on intensive care unit until hospital discharge, or maximal until postoperative day 5
Primary	Incidence of Postoperative Delirium - Confusion Assessment Method (CAM)	Postoperative delirium rate, defined according to positive Confusion Assessment Method (CAM)	Patients will be followed on peripheral ward until hospital discharge, or maximal until postoperative day 5
Secondary	Incidence of postoperative cognitive deficit (POCD) - CANTAB	POCD will be measured by a defined Cambridge Neuropsychological Test Automated Battery (CANTAB) on the day before the operation and after 3 months	Up to 3 months
Secondary	Incidence of postoperative cognitive deficit (POCD) - MMSE	POCD will be measured by Mini Mental State Examination (MMSE) on the day before the Operation, on day 5 and after 3 months	Up to 3 months
Secondary	Incidence of Neurocognitive disorder	Neurocognitive Disorder is evaluated according to DSM-V (postoperative cognitive deficit, activities of daily living, instrumental activities of daily living, subjective memory sensing.	Up to 3 months
Secondary	Incidence of postoperative cognitive deficit (POCD) - Word pair recognition test	POCD will be measured by Nürnberger-Altersinventar-Test - word pair recognition test on the day before the operation, day 1 ,3 and 5	Up to 5 days
Secondary	Post-operative, bi-frontal alpha-band power	Bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code	Up to discharge from the recovery room
Secondary	Bi-frontal overall EEG band power	Postoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code	Up to discharge from the recovery room
Secondary	Burst suppression duration	Intraoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), raw EEG analysis	During anesthesia procedure
Secondary	Pain monitoring	Intraoperative pain monitoring is measured by Nociception Level Index (NOL	During anesthesia procedure
Secondary	Duration of Delirium (DSM-V)	Postoperative duration of delirium, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)	Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Secondary	Duration of Delirium (Nu-DESC)	Postoperative duration of delirium, defined according to Nursing Delirium Screening Scale (Nu-DESC)	Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Secondary	Duration of Delirium (CAM-ICU)	Postoperative duration of delirium, defined according to Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)Confusion Assessment Method (CAM), Chart Review	Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Secondary	Duration of Delirium (CAM)	Postoperative duration of delirium, defined according to Confusion Assessment Method (CAM)	Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Secondary	Intensive care unit length of stay	Intensive care unit length of staywill be assessed by chart review at hospital discharge.	Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Secondary	Hospital length of stay	Hospital length of stay will be assessed by chart review at 3 months.	Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Mortality	Mortality will be assessed by chart review at 3 months.	Up to 3 months