Postoperative DeliriumNCT03879850
Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Postoperative Delirium
- Type of treatment
- Injection or infusion
- How many people
- 348 participants
- Where
- 1 siteGermany
- Study dates
- 19 Mar 2019to 28 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - i.v. Propofol (Propofol group) or volatile anesthetic agent as Sevoflurane or Desflurane (Volatile group) - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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,
- when intraoperative use of any other anesthetic agent for induction as Propofol occurred or
- by use of any other anesthetic agent for anesthesia maintenance other than Propofol or volatile anesthetics as Sevoflurane or Desflurane or
- when anesthesia agents as Ketamine, Nitrous oxide, Etomidate or Dexmedetomidine were given or
- if body temperature drops below 34° or rises above 38° during surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
About this study
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).
Read the 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Postoperative Delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - i.v. Propofol - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients. | |
| Volatile group | This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - volatile anesthetic agent as Sevoflurane or Desflurane - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Patients will be follow until hospital discharge, or maximal until postoperative day 5
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)
Measured: Patients will be follow until hospital discharge, or maximal until postoperative day 5
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
Measured: Patients will be followed on intensive care unit until hospital discharge, or maximal until postoperative day 5
Incidence of Postoperative Delirium - Confusion Assessment Method (CAM)
Postoperative delirium rate, defined according to positive Confusion Assessment Method (CAM)
Measured: Patients will be followed on peripheral ward until hospital discharge, or maximal until postoperative day 5
Secondary outcomes (15)
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
Measured: Up to 3 months
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
Measured: Up to 3 months
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.
Measured: Up to 3 months
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
Measured: Up to 5 days
Post-operative, bi-frontal alpha-band power
Bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code
Measured: Up to discharge from the recovery room
Bi-frontal overall EEG band power
Postoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code
Measured: Up to discharge from the recovery room
Burst suppression duration
Intraoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), raw EEG analysis
Measured: During anesthesia procedure
Pain monitoring
Intraoperative pain monitoring is measured by Nociception Level Index (NOL
Measured: During anesthesia procedure
Duration of Delirium (DSM-V)
Postoperative duration of delirium, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
Measured: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Duration of Delirium (Nu-DESC)
Postoperative duration of delirium, defined according to Nursing Delirium Screening Scale (Nu-DESC)
Measured: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
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
Measured: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Duration of Delirium (CAM)
Postoperative duration of delirium, defined according to Confusion Assessment Method (CAM)
Measured: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Intensive care unit length of stay
Intensive care unit length of staywill be assessed by chart review at hospital discharge.
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
Hospital length of stay will be assessed by chart review at 3 months.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Mortality
Mortality will be assessed by chart review at 3 months.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start19 Mar 2019
- Primary completion24 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Forschung (Projekt No 409495393)
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879850
- Sponsor's protocol ID
- EPOD
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2019
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Markus M, Widmann S, Jansche J, Kreuzer M, Windmann V, Leroy S, Brown EN, Spies C, Koch S. Electroencephalographic Monitoring in the Recovery Room for Identification of Patients at Risk for Postoperative Delirium. Anesthesiology. 2026 Aug 1;145(2):333-346. doi: 10.1097/ALN.0000000000006096. Epub 2026 Apr 15.
PubMed 41983562
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly
- ClinicalTrials.gov ID
- NCT03879850
- Acronym / sponsor ID
- EPOD
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutsche Forschung (Projekt No 409495393)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | – | –This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - i.v. Propofol - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients. |
| Volatile group | – | –This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - volatile anesthetic agent as Sevoflurane or Desflurane - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - i.v. Propofol (Propofol group) or volatile anesthetic agent as Sevoflurane or Desflurane (Volatile group) - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Patients with a history of neurological or psychiatric disorders
- Known carotid artery Stenosis
- Obstructive sleep apnea Syndrome
- Planned neurosurgery
- Current medication of tranquilizers / antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Delirium- Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
Time frame: Patients will be follow until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
Incidence of Postoperative Delirium - Nursing Delrium Scale (Nu-DESC)
Time frame: Patients will be follow until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to ≥ 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC)
Incidence of Postoperative Delirium - Intensive Care Unit (CAM-ICU)
Time frame: Patients will be followed on intensive care unit until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score
Incidence of Postoperative Delirium - Confusion Assessment Method (CAM)
Time frame: Patients will be followed on peripheral ward until hospital discharge, or maximal until postoperative day 5
Postoperative delirium rate, defined according to positive Confusion Assessment Method (CAM)
15 secondary outcomes
Incidence of postoperative cognitive deficit (POCD) - CANTAB
Time frame: Up to 3 months
Incidence of postoperative cognitive deficit (POCD) - MMSE
Time frame: Up to 3 months
Incidence of Neurocognitive disorder
Time frame: Up to 3 months
Incidence of postoperative cognitive deficit (POCD) - Word pair recognition test
Time frame: Up to 5 days
Post-operative, bi-frontal alpha-band power
Time frame: Up to discharge from the recovery room
Bi-frontal overall EEG band power
Time frame: Up to discharge from the recovery room
Burst suppression duration
Time frame: During anesthesia procedure
Pain monitoring
Time frame: During anesthesia procedure
Duration of Delirium (DSM-V)
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Duration of Delirium (Nu-DESC)
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Duration of Delirium (CAM-ICU)
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Duration of Delirium (CAM)
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Mortality
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Derived from this study: PubMed 41983562Markus M, Widmann S, Jansche J, Kreuzer M, Windmann V, Leroy S, Brown EN, Spies C, Koch S. Electroencephalographic Monitoring in the Recovery Room for Identification of Patients at Risk for Postoperative Delirium. Anesthesiology. 2026 Aug 1;145(2):333-346. doi: 10.1097/ALN.0000000000006096. Epub 2026 Apr 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) (time frame: Patients will be follow until hospital discharge, or maximal until postoperative day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.