Delirium, Dementia, Amnestic, Cognitive DisordersNCT00512200
Postoperative Cognitive Dysfunction in Geriatric Patients
An observational study of Delirium, Dementia, Amnestic, Cognitive Disorders and Postoperative Complications, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Geriatric patients have a high risk of developing postoperative cognitive deficits. Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are administered in the perioperative setting. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Dementia, Amnestic, Cognitive Disorders, Postoperative Complications, Memory Disorders
- How many people
- 280 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2007to Feb 2012
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing elective major surgery under general anesthesia
Who may be able to join
- Elective surgical procedure under general anaesthesia
Who cannot join
- History of cerebrovascular disease
- Mini Mental status <23
- Cardiac surgery
- Neurosurgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesia, University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Postoperative Cognitive Dysfunction in Geriatric Patients: the Role of Intraoperative Cerebral Perfusion and Perioperative Anticholinergic Medication
Geriatric patients have a high risk of developing postoperative cognitive deficits. Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are administered in the perioperative setting. This study will investigate the role of these two factors in patients aged 65 or older undergoing elective surgical procedures under general aesthesia. Non-invasive techniques will be used to monitor intraoperative cerebral perfusion and anticholinergic activity in the patient's blood is determined. Data will be compared to those of a young (20-40 year old) group of patients undergoing elective surgical procedures using an identical anesthetic technique. A second control group of healthy volunteers older than 65 will be investigated to quantify practice effects with repeated testing of cognitive functions.
- Conditions
- Delirium, Dementia, Amnestic, Cognitive Disorders, Postoperative Complications, Memory Disorders
- Medical subject headings
- Neurocognitive Disorders, Postoperative Complications, Memory Disorders
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 |
|---|---|---|
| Case | Patients aged 65 or older | |
| Control | Patients aged 20 to 40 | |
| Control 2 | Healthy volunteers aged 65 or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function due to surgery under general aesthesia
cognitive function measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neurological test battery
Measured: cognitive function measured prior to and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2012
- Study completionFeb 2012
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 Delirium, Dementia, Amnestic, Cognitive DisordersStudies of the same condition, open and under way.
- 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luzius A Steiner, MD, Prof., Principal investigator, Department of Anaesthesia, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512200
- Sponsor's protocol ID
- EK 75/07
- Status last verified
- Oct 2015
- First submitted
- 6 Aug 2007
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Goettel N, Patet C, Rossi A, Burkhart CS, Czosnyka M, Strebel SP, Steiner LA. Monitoring of cerebral blood flow autoregulation in adults undergoing sevoflurane anesthesia: a prospective cohort study of two age groups. J Clin Monit Comput. 2016 Jun;30(3):255-64. doi: 10.1007/s10877-015-9754-z. Epub 2015 Aug 19.
PubMed 26285741
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction in Geriatric Patients: the Role of Intraoperative Cerebral Perfusion and Perioperative Anticholinergic Medication
- ClinicalTrials.gov ID
- NCT00512200
- Acronym / sponsor ID
- EK 75/07
- Conditions
- Delirium, Dementia, Amnestic, Cognitive Disorders, Postoperative Complications, Memory Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Aug 2007 (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.
Geriatric patients have a high risk of developing postoperative cognitive deficits. Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are administered in the perioperative setting. This study will investigate the role of these two factors in patients aged 65 or older undergoing elective surgical procedures under general aesthesia. Non-invasive techniques will be used to monitor intraoperative cerebral perfusion and anticholinergic activity in the patient's blood is determined. Data will be compared to those of a young (20-40 year old) group of patients undergoing elective surgical procedures using an identical anesthetic technique. A second control group of healthy volunteers older than 65 will be investigated to quantify practice effects with repeated testing of cognitive functions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients aged 65 or older |
| Control | – | –Patients aged 20 to 40 |
| Control 2 | – | –Healthy volunteers aged 65 or older |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing elective major surgery under general anesthesia
Key inclusion criteria (1 listed)
- Elective surgical procedure under general anaesthesia
Key exclusion criteria (4 listed)
- History of cerebrovascular disease
- Mini Mental status <23
- Cardiac surgery
- Neurosurgery
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
Change in cognitive function due to surgery under general aesthesia
Time frame: cognitive function measured prior to and after surgery
cognitive function measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neurological test battery
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 16 Oct 2015.
- Derived from this study: PubMed 26285741Goettel N, Patet C, Rossi A, Burkhart CS, Czosnyka M, Strebel SP, Steiner LA. Monitoring of cerebral blood flow autoregulation in adults undergoing sevoflurane anesthesia: a prospective cohort study of two age groups. J Clin Monit Comput. 2016 Jun;30(3):255-64. doi: 10.1007/s10877-015-9754-z. Epub 2015 Aug 19.
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.
Luzius A Steiner, MD, Prof. principal investigator
Department of Anaesthesia, University Hospital Basel
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 Delirium, Dementia, Amnestic, Cognitive Disorders and Postoperative Complications, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 4 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 16 Oct 2015. 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 Switzerland. 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?
Change in cognitive function due to surgery under general aesthesia (time frame: cognitive function measured prior to and after surgery). 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 NCT00512200, 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 16 Oct 2015; AzTrials last refreshed its copy on 26 Oct 2026.