Evaluation of cognitive dysfunction after surgery
Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany · NCT02832193
This study looks at how surgery might affect thinking and memory in patients by comparing their cognitive performance before and after the operation to those who didn't have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT02832193 on ClinicalTrials.gov |
What this trial studies
This observational registry collects data on postoperative cognitive dysfunction (pNCD) from patients undergoing elective surgeries lasting at least 60 minutes. It employs a variety of cognitive tests, both computerized and paper-based, to assess cognitive performance before and after surgery at multiple follow-up points. The study aims to estimate the prevalence and incidence of pNCDs by comparing surgical patients' cognitive outcomes with non-surgical control groups, using established cognitive assessment methodologies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 100 who are scheduled for elective surgeries lasting at least 60 minutes.
Not a fit: Patients with significant neurological deficits, severe impairments in hearing or vision, or those unable to communicate in German may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding and management of cognitive dysfunction following surgery, leading to better patient outcomes.
How similar studies have performed: Other studies have explored postoperative cognitive dysfunction, but this specific approach of a comprehensive observational registry is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Study Group Inclusion Criteria: * 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 Exclusion Criteria: * 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 Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Berlin and 1 other locations
- Irmgard Landgraf — Berlin, Germany (NOT_YET_RECRUITING)
- Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin — Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Claudia Spies, MD, Prof.
- Email: claudia.spies@charite.de
- Phone: +49 30 450 5510 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Cognitive Dysfunction