Postoperative Cognitive DysfunctionNCT02832193
Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin
An observational study of Postoperative Cognitive Dysfunction, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 5,000 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2009to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female patients undergoing surgery, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
Who may be able to join
- Age 18 -100 years
- Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
- Written informed consent to participate after having been properly instructed
- Age 18 - 100 years
- Male or female patients (ASA Status I, II+III)
- No planned surgery during the next 3 months
- No surgery during the past 6 months before study inclusion
- Written informed consent to participate after having been properly instructed
Who cannot join
- Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- Accommodation in an institution due to an official or judicial order
- Insufficient knowledge of German language
- Members of the hospital staff
- Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone
- Illiteracy
Show all 15Show fewer
- Patients who had a history of neurologic deficits (e.g. stroke, history of seizures, etc.)
- Hearing impairment that severely affects the neuropsychological testing.
- Visual impairment that severely affects the neuropsychological testing.
- Participation in other prospective clinical interventional trials
- Control Group
- Insufficient knowledge of German language Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- Neuropsychiatric conditions that severely affect the neuropsychological testing
- Hearing impairment that severely affects the neuropsychological testing
- Visual impairment that severely affects the neuropsychological testing
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
Irmgard Landgraf
Berlin, 12163
Irmgard Landgraf, MD, +49 30 450 85726877, praxislandgraf@gmail.com
- Recruiting
Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
Claudia Spies, MD, Prof., +49 30 450 55 10 01, claudia.spies@charite.de
Claudia Spies, MD, Prof.
About this study
Official title: Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin
Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs.
Read the detailed description
Perioperative cognitive trajectories (Perioperative neurocognitive disorders [pNCDs]) are described with formal cognitive testing (neurocognitive test battery). Definitions are based on current nomenclature recommendations (Evered et al.) according to DSM-V criteria including a multi-component cognitive test battery comparing baseline and postoperative follow-up testing of patients with cognitive test performance of non-surgical control groups.Cognitive concern and functional ability are described with items from questionnaires, e.g. IQCODE, MMQ, GDS, ADL/IADL and others specific to the respective study design.
Repeated cognitive testing with a battery of computerized neuropsychological tests (Cambridge Neuropsychological Test Automated Battery [CANTAB®]) and non computerized (paper based)tests (e.g. trailmaking test, Grooved pegboard test, Stroop color word interference test, animal naming test, etc.) are performed at preoperative baseline, after 5-7 days and at three months follow up, 1 year, 2 years and 5 years follow-up according to the study design of the registered studies.
Different calculation methods will be applied to the cognitive test data, primarily the dichotomousapproach established by Rasmussen et al. in the International Study on postoperative cognitive deficits (ISPOCD). This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters). Additional calculation methods like "g-factor", "GCP" and arbitrary definitions e.g. "20.20- rule" will be used for detailed methodologic evaluation.
In two subprojects we plan to describe domain-specific changes in formal cognitive testing over the registered surgical cohorts.
Subproject 1-Analyses will be performed in joint evaluation with Monument Therapeutics (Spin off Cambridge Cognition). The analyses aim to :
- Describe cognitive change based on raw cognitive data from the applied cognitive test battery (computerized tests with CANTAB eclipse, CANTAB research suite, CANTAB connect and non-computerized tests)
- Identify predisposing factors (e.g. patient characteristics, biomarkers, medications) predictive of cognitive decline following surgery
- Identify the cognitive domains most sensitive to neuropsychological change following surgery
Subproject 2-Analyses will be performed in joint evaluation with Cambridge Cognition. The analyses aim to :
Facilitate the use of data collected from non-surgical controls as normative material for future studies in the research area.
- Conditions
- Postoperative Cognitive Dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
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 |
|---|---|---|
| Study group | POCD data of study patients of the following studies: Phydelio - Eudract.-No.: 2008-007237-47 - 08/0618 ZS EK11 Neuprodex - Eudract-No.: 2013 -000823-15 - 13/0491 ZSEK11 BioCog - EA2/092/14 Cognitive Outcome after two stage liver operation - EA1/296/12 ReCosa - EA1/056/13 Hypnoc - EA1/273/11 Sudoco - EA1/242/08 Peratecs - EA1/241/08 Hipster - Eudract.-No.: 2009-016043-19 100/10 ZS EK15 Pain-Long-EA2/041/17 PCI - EA2/024/18 PODSPA - EA4/138/18, PRÄP-GO -EA1/225/19, ANA-PRÄP-Go (EA1/266/20) Further studies from the Department of Anesthesiology and Operative Intensive Care Medince (CCM/CVK), Charité - Universitätsmedizin Berlin | |
| Control group I | POCD data of prospective control subjects/patients (ASA I+II+III) and POCD data of control subjects/patients of the following studies: Neuprodex - Eudract-No.: 2013 -000823-15 - 13/0491 ZSEK11 Phydeliostudie - Eudract.-No.: 2008-007237-47 - 08/0618 ZS EK11 BioCog - EA2/092/14 Cognitive Outcome after two stage liver operation - EA1/296/12 Hypnoc - EA1/273/11 Sudoco - EA1/242/08 Peratecs - EA1/241/08 Hipster - Eudract.-No.: 2009-016043-19 100/10 ZS EK15 BioCog-Studie - EA2/092/14 REACT-Studie - EA2/091/15 PAINLONG-Studie - EA2/041/17 PCI - EA2/024/18 PODSPA - EA4/138/18, PRÄP-GO -EA1/225/19, ANA-PRÄP-Go (EA1/266/20) Further studies from the Department of Anesthesiology and Operative Intensive Care Medince (CCM/CVK), Charité - Universitätsmedizin Berlin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Disorder (NCD)
Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.
Measured: Up to 1 year
Postoperative cognitive dysfunction (POCD)
Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.
Measured: Up to 1 year
Secondary outcomes (56)
Suspected neurocognitive disorder due to MiniCog
The MiniCog is used for cognitive screening. A cut-off value of <3 points is interpreted possible mild / major NCD. The Mini-Cog consists of a sub-test for word memory skills and a clock drawing test.
Measured: Up to 5 years
Suspected dementia from MOCA
The Montreal Cognitive Assessment (MOCA) with cut-offs according to normative age-adjusted values is used as dementia screening. The MOCA consists of 13 items, which are rated on a scale from 0 to 30 points.
Measured: Up to 5 years
Neurocognitive Disorder (NCD)
Mild / major neurocognitive disorder (mild / major NCD) 60months postoperatively.
Measured: Up to 5 years
Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')
The non-computerized neuropsychological trail making test is used as an indicator screening test for relevant cognitive changes after the operation. The cut-off is an increase in TMT-B test performance of> 55 seconds three and / or 12 months after the operation compared to the baseline value.
Measured: Up to 5 years
Findings from outpatient neurocognitive evaluation (memory clinic)
Results from patient neurocognitive assessment in a memory clinic are evaluated.
Measured: Up to 1 year
Neuroimaging
Technique to image the nervous system.
Measured: Up to 5 years
Normative database
Establishment of a norm database for deriving normative data in a cooperation between the Clinial Research Unit Berlin/Institute of Health (BIH), the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK) at Charité Universitätsmedizin Berlin and Cambridge Cognition.
Measured: Up to 5 years
Perioperative cognitive disorders
Perioperative cognitive disorders for different surgical cohorts are evaluated to describe domain-specific changes over time in formal cognitive tests. These analyzes are carried out in a joint evaluation with Monument Therapeutics as part of a cooperation agreement
Measured: Up to 5 years
Computerized cognitive data
Computerized cognitive data from CANTAB-research suite, CANTAB eclipse and CANTAB connect
Measured: Up to 5 years
Paper-based, non-computerized, cognitive test data
Paper-based, non-computerized, cognitive test data are data from such as IQ equivalent (e.g. MWT-A), MMSE, MOCA, MMQ, Mini-Cog, etc.
Measured: Up to 5 years
Socio-economic Information 1
Soci-economic information is collected by FIMA
Measured: Up to 5 years
Socio-economic Information 2
Soci-economic information is collected by a questionnaire according to Nikolaus 1. Subscale
Measured: Up to 5 years
Comorbidities
Comorbidities are new diagnoses from hospital records.
Measured: Up to 5 years
Charlson comorbidity index
Comorbidity scores
Measured: Up to 5 years
Lifestyle Risks 1
Consumption of alcohol per week.
Measured: Up to 5 years
Lifestyle Risks 2
Consumption of tobacco and nicotine is measured by Fagerström Test for Cigarette Dependence (FTCD). Questionnaire scored 0-10 points with Total Score equal to the sum of all points
Measured: Up to 5 years
Level of education
Level of education is measured by ISCED
Measured: Up to 5 years
Incidence of postoperative delirium
Incidence of postoperative delirium is measured by DDS, DSM-V, CAM/CAM-ICU, NuDESC and Chart review
Measured: Up to 5 years
Duration of postoperative delirium
The Duration of postoperative Delirium is measured in days
Measured: Up to 5 years
Severity of postoperative delirium 1
Severity of delirium 1 is measured by Delirium Detection Score (DDS). The DDS is composed of eight criteria (orientation, hallucination, agitation, anxiety, seizures, tremor, paroxysmal sweating, and altered sleep- wake rhythm). Each item is cored 0,1,4, or 7 points for a possible total score of 0 to 56). Positive if >7.
Measured: Up to 5 years
Severity of postoperative delirium 2
Severity of delirium 2 is measured by Confusion assessment method-short (CAM-S). This is a CAM-based scoring system for delirium severity. The CAM-S uses the same items as the original CAM and rates each symptom 0 for absent, 1 for mild, or 2 for marked; acute onset of fluctuation receives 0 (absent) or 1 (present) (scored 0-10, higher worse).
Measured: Up to 5 years
Severity of postoperative delirium 3
Severity of delirium 3 is measured by DSR-R-98. DRS-R-98 is 16 items clinician rated scale. Total Item: 16 = 3 (for diagnosis) + 13 (for severity).
Measured: Up to 5 years
Severity of postoperative delirium 4
Severity of delirium 4 is measured by ICDSC. Give a score of "1" to each of the 8 items below if the patient clearly meets the criteria defined in the scoring instructions. Give a score of "0" if there is no manifestation orunable to score. If the patient scores >4, notify the physician. The diagnosis of delirium is made following clinical assessment. assessment.
Measured: Up to 5 years
Severity of postoperative delirium 5
Severity of delirium 5 is measured by Nursing Delirium Screening Scale (Nu-DESC). The Nu-DESC is a scale that evaluates the severity of the 5 delirium characteristics on a scale of 0 (not present) to 2 (severe) and takes only 1-2 min to complete, based on the nurses' observations of the patient's behavior during their shifts.
Measured: Up to 5 years
Length of hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Measured: Up to 5 years
Quality of life - relatives
Quality of life is measured by CarerQoL
Measured: Up to 5 years
Quality of life - self 1
Quality of life is measured by EQ-5D.An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.
Measured: Up to 5 years
Quality of life - self 2
Quality of life is measured by WHO-5. WHO-5 is a short and generic global rating scale measuring subjective well-being, the respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score ranges from 0 (absence of well-being) to 25 (maximal well-being). Scores are then converted to a percentage scale from 0 (absent) to 100 (maximal). Higher scores represent greater psychological well-being.
Measured: Up to 5 years
Functional impairment (IADL) 1
Instrumental Activities of Daily Living (IADLs) < 8
Measured: Up to 5 years
Functional impairment (ADL) 2
Activities of Daily Living (ADLs) < 100
Measured: Up to 5 years
Depression 1
Depression 1 is measured by PHQ-8
Measured: Up to 5 years
Depression 2
Depression 2 is measured by GDS
Measured: Up to 5 years
Anxiety scales
Anxiety is measured by GAD-7
Measured: Up to 5 years
Pain
Pain is measured by different scales, e.g. Numeric Rating Scale
Measured: Up to 5 years
Depth of sedation
The sedation is emasured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.
Measured: Up to 5 years
Sedation
Sedation is measured by the Richmond Agitation Sedation Scale
Measured: Up to 5 years
Type of operation
Type of operation is measured by OPS-Code.
Measured: Up to 5 years
Type of anesthesia
There are four main categories of anesthesia used during surgery and other procedures: general anesthesia, regional anesthesia, sedation (sometimes called "monitored anesthesia care"), and local anesthesia.
Measured: Up to 5 years
Type of concomitant medication
The medication administered during the hospital stay is documented.
Measured: Up to 5 years
Anticholinergic Load
Measured by anticholinergic drug scale
Measured: Up to 5 years
Frailty
Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.
Measured: Up to 5 years
Number of participants with changes in laboratory values 1
Laboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.
Measured: Up to 5 years
Number of participants with changes in laboratory values 2
Laboratory results in the hospital from serum samples
Measured: Up to 5 years
Number of participants with changes in laboratory values 3
Laboratory results in the hospital from urine samples
Measured: Up to 5 years
Number of participants with changes in laboratory values 4
Laboratory results in the hospital from stool samples
Measured: Up to 5 years
Perioperative Electroencephalography
Electroencephalography (EEG)- Mapping with electrodes.
Measured: During hospital stay an expected avarage of 7 days
Nutritional status 1
Nutritional status 1 is measured by calf circumference
Measured: Up to five years
Nutritional status 2
Nutritional status 2 is measured by arm circumference
Measured: Up to five years
Nutritional status 3
Nutritional status 3 is measured by changes in weight
Measured: Up to five years
Nutritional status 4
Nutritional status 4 is measured by changes in body mass index
Measured: Up to five years
Nutritional status 5
Nutritional status 5 is measured by questions regarding microbiome
Measured: Up to five years
Nutritional status 6
Nutritional status 6 is measured by Medi-Score
Measured: Up to five years
Nutritional status 7
Nutritional status 7 is measured by MNA-SF
Measured: Up to five years
Nutritional status 8
Nutritional status 8 is measured by Sarcopenia, which is identified by criterion 1: low muscle strength, criterion 2: low muscle quantity and criterion 3: low physical performance. Probable sarcopenia is identified by Criterion 1. Diagnosis is confirmed by additional documentation of Criterion 2.
If Criteria 1, 2 and 3 are all met, sarcopenia is considered severe.
Measured: Up to five years
Inhospital diet
Inhospital diet is measured by patient record.
Measured: Up to five years
Eating habits
Eating habits are measured by patient survey.
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMar 2009
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- 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
- NCT02832193
- Sponsor's protocol ID
- POCD-Registry
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2016
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.
PubMed 11207462Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
PubMed 30336844
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin
- ClinicalTrials.gov ID
- NCT02832193
- Acronym / sponsor ID
- POCD-Registry
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- 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.
Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs.
Detailed description
Perioperative cognitive trajectories (Perioperative neurocognitive disorders [pNCDs]) are described with formal cognitive testing (neurocognitive test battery). Definitions are based on current nomenclature recommendations (Evered et al.) according to DSM-V criteria including a multi-component cognitive test battery comparing baseline and postoperative follow-up testing of patients with cognitive test performance of non-surgical control groups.Cognitive concern and functional ability are described with items from questionnaires, e.g. IQCODE, MMQ, GDS, ADL/IADL and others specific to the respective study design.
Repeated cognitive testing with a battery of computerized neuropsychological tests (Cambridge Neuropsychological Test Automated Battery [CANTAB®]) and non computerized (paper based)tests (e.g. trailmaking test, Grooved pegboard test, Stroop color word interference test, animal naming test, etc.) are performed at preoperative baseline, after 5-7 days and at three months follow up, 1 year, 2 years and 5 years follow-up according to the study design of the registered studies.
Different calculation methods will be applied to the cognitive test data, primarily the dichotomousapproach established by Rasmussen et al. in the International Study on postoperative cognitive deficits (ISPOCD). This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters). Additional calculation methods like "g-factor", "GCP" and arbitrary definitions e.g. "20.20- rule" will be used for detailed methodologic evaluation.
In two subprojects we plan to describe domain-specific changes in formal cognitive testing over the registered surgical cohorts.
Subproject 1-Analyses will be performed in joint evaluation with Monument Therapeutics (Spin off Cambridge Cognition). The analyses aim to :
- Describe cognitive change based on raw cognitive data from the applied cognitive test battery (computerized tests with CANTAB eclipse, CANTAB research suite, CANTAB connect and non-computerized tests)
- Identify predisposing factors (e.g. patient characteristics, biomarkers, medications) predictive of cognitive decline following surgery
- Identify the cognitive domains most sensitive to neuropsychological change following surgery
Subproject 2-Analyses will be performed in joint evaluation with Cambridge Cognition. The analyses aim to :
Facilitate the use of data collected from non-surgical controls as normative material for future studies in the research area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –POCD data of study patients of the following studies: Phydelio - Eudract.-No.: 2008-007237-47 - 08/0618 ZS EK11 Neuprodex - Eudract-No.: 2013 -000823-15 - 13/0491 ZSEK11 BioCog - EA2/092/14 Cognitive Outcome after two stage liver operation - EA1/296/12 ReCosa - EA1/056/13 Hypnoc - EA1/273/11 Sudoco - EA1/242/08 Peratecs - EA1/241/08 Hipster - Eudract.-No.: 2009-016043-19 100/10 ZS EK15 Pain-Long-EA2/041/17 PCI - EA2/024/18 PODSPA - EA4/138/18, PRÄP-GO -EA1/225/19, ANA-PRÄP-Go (EA1/266/20) Further studies from the Department of Anesthesiology and Operative Intensive Care Medince (CCM/CVK), Charité - Universitätsmedizin Berlin |
| Control group I | – | –POCD data of prospective control subjects/patients (ASA I+II+III) and POCD data of control subjects/patients of the following studies: Neuprodex - Eudract-No.: 2013 -000823-15 - 13/0491 ZSEK11 Phydeliostudie - Eudract.-No.: 2008-007237-47 - 08/0618 ZS EK11 BioCog - EA2/092/14 Cognitive Outcome after two stage liver operation - EA1/296/12 Hypnoc - EA1/273/11 Sudoco - EA1/242/08 Peratecs - EA1/241/08 Hipster - Eudract.-No.: 2009-016043-19 100/10 ZS EK15 BioCog-Studie - EA2/092/14 REACT-Studie - EA2/091/15 PAINLONG-Studie - EA2/041/17 PCI - EA2/024/18 PODSPA - EA4/138/18, PRÄP-GO -EA1/225/19, ANA-PRÄP-Go (EA1/266/20) Further studies from the Department of Anesthesiology and Operative Intensive Care Medince (CCM/CVK), Charité - Universitätsmedizin Berlin |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients undergoing surgery, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
Key inclusion criteria (8 listed)
- Age 18 -100 years
- Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
- Written informed consent to participate after having been properly instructed
- Age 18 - 100 years
- Male or female patients (ASA Status I, II+III)
Key exclusion criteria (15 listed)
- Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- Accommodation in an institution due to an official or judicial order
- Insufficient knowledge of German language
- Members of the hospital staff
- Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone
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
Neurocognitive Disorder (NCD)
Time frame: Up to 1 year
Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.
Postoperative cognitive dysfunction (POCD)
Time frame: Up to 1 year
Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.
56 secondary outcomes
Suspected neurocognitive disorder due to MiniCog
Time frame: Up to 5 years
Suspected dementia from MOCA
Time frame: Up to 5 years
Neurocognitive Disorder (NCD)
Time frame: Up to 5 years
Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')
Time frame: Up to 5 years
Findings from outpatient neurocognitive evaluation (memory clinic)
Time frame: Up to 1 year
Neuroimaging
Time frame: Up to 5 years
Normative database
Time frame: Up to 5 years
Perioperative cognitive disorders
Time frame: Up to 5 years
Computerized cognitive data
Time frame: Up to 5 years
Paper-based, non-computerized, cognitive test data
Time frame: Up to 5 years
Socio-economic Information 1
Time frame: Up to 5 years
Socio-economic Information 2
Time frame: Up to 5 years
Comorbidities
Time frame: Up to 5 years
Charlson comorbidity index
Time frame: Up to 5 years
Lifestyle Risks 1
Time frame: Up to 5 years
Lifestyle Risks 2
Time frame: Up to 5 years
Level of education
Time frame: Up to 5 years
Incidence of postoperative delirium
Time frame: Up to 5 years
Duration of postoperative delirium
Time frame: Up to 5 years
Severity of postoperative delirium 1
Time frame: Up to 5 years
Severity of postoperative delirium 2
Time frame: Up to 5 years
Severity of postoperative delirium 3
Time frame: Up to 5 years
Severity of postoperative delirium 4
Time frame: Up to 5 years
Severity of postoperative delirium 5
Time frame: Up to 5 years
Length of hospital stay
Time frame: Up to 5 years
Quality of life - relatives
Time frame: Up to 5 years
Quality of life - self 1
Time frame: Up to 5 years
Quality of life - self 2
Time frame: Up to 5 years
Functional impairment (IADL) 1
Time frame: Up to 5 years
Functional impairment (ADL) 2
Time frame: Up to 5 years
Depression 1
Time frame: Up to 5 years
Depression 2
Time frame: Up to 5 years
Anxiety scales
Time frame: Up to 5 years
Pain
Time frame: Up to 5 years
Depth of sedation
Time frame: Up to 5 years
Sedation
Time frame: Up to 5 years
Type of operation
Time frame: Up to 5 years
Type of anesthesia
Time frame: Up to 5 years
Type of concomitant medication
Time frame: Up to 5 years
Anticholinergic Load
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 11207462Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.
- Background: PubMed 30336844Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Charite University, Berlin, Germany at 2 sites 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Spies, MD, Prof. (+49 30 450 5510 01, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive Disorder (NCD) (time frame: Up to 1 year). The study lists 2 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 NCT02832193, which also lists 2 linked publications.
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 26 Nov 2025.