NCT02832193

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Mar 2009Dec 2027

Study Start

First participant enrolled

March 1, 2009

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

18.8 years

First QC Date

June 28, 2016

Last Update Submit

November 25, 2025

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Neurocognitive Disorder (NCD)

    Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.

    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.

    Up to 1 year

Secondary Outcomes (56)

  • Suspected neurocognitive disorder due to MiniCog

    Up to 5 years

  • Suspected dementia from MOCA

    Up to 5 years

  • Neurocognitive Disorder (NCD)

    Up to 5 years

  • Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')

    Up to 5 years

  • Findings from outpatient neurocognitive evaluation (memory clinic)

    Up to 1 year

  • +51 more secondary outcomes

Other Outcomes (7)

  • Demographics

    Up to 5 years

  • Neurological diseases

    Up to 5 years

  • Waist circumference

    Up to 5 years

  • +4 more other outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • Age 18 - 100 years
  • Male or female patients (ASA Status I, II+III)
  • No planned surgery during the next 3 months
  • Written informed consent to participate after having been properly instructed
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Irmgard Landgraf

Berlin, 12163, Germany

NOT YET RECRUITING

Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 11207462BACKGROUND

  • Evered 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.

    PMID: 30336844BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 5510 01claudia.spies@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK)

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 14, 2016

Study Start

March 1, 2009

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)