Cognitive Function AbnormalNCT04101006
Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function
An observational study of Cognitive Function Abnormal and Anesthesia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Cerebral blood flow is tightly regulated to ensure constant cerebral perfusion independently from systemic blood pressure fluctuations. This mechanism is termed cerebrovascular autoregulation and preserves adequate cerebral perfusion in a range between 50 and 150 mmHg of cerebral perfusion pressure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Function Abnormal, Anesthesia, Surgery
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 14 Apr 2016to 3 Apr 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: screening of patients scheduled for preanesthesia evaluation prior to major non-cardiac/non-vascular surgery
Who may be able to join
- elective major non-cardiac/non-vascular surgery
- anticipated surgical duration >120 minutes
- age >= 60 years
- indication for invasive blood pressure measurement
- native German speaker
Who cannot join
- history of cerebrovascular disease
- preexisting cognitive impairment
- history or presence of neurological disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Cerebrovascular Autoregulation During Major Non-cardiac Surgery and Risk for Postoperative Cognitive Dysfunction in Elderly Patients
Cerebral blood flow is tightly regulated to ensure constant cerebral perfusion independently from systemic blood pressure fluctuations. This mechanism is termed cerebrovascular autoregulation and preserves adequate cerebral perfusion in a range between 50 and 150 mmHg of cerebral perfusion pressure. Upper and lower autoregulatory limits may vary individually. Beyond the autoregulatory range the protective autoregulatory response is lost, facilitating cerebral ischemia or hyperemia.
The cerebrovascular response may be altered during general anesthesia, through direct effects of anesthetic agents on the vascular tone, changes of arterial partial pressure of carbon dioxide or the administration of vasoactive substances. The association of perioperative impairment of cerebral autoregulation and postoperative cognitive function has been discussed controversially.
Read the detailed description
- continuous monitoring of cerebrovascular autoregulation using the correlation method
- based on near-infrared spectroscopy and invasive blood pressure measurement an index (COx) will be calculated
- autoregulation monitoring from anesthesia induction until emergence from anesthesia
- assessment of preoperative cognitive function during preanesthesia evaluation or on the day before surgery
- assessment of postoperative cognitive function between day 3 and 14 following surgery
- evaluation of subjective cognitive complaints or attention deficits 3 months after surgery
- Conditions
- Cognitive Function Abnormal, Anesthesia, Surgery
- Medical subject headings
- Cognition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative change of cognitive function from baseline
change of cognitive function following surgery compared with preoperative cognitive performance, defined as: z-score <-1.96/>1.96 in two or more neuropsychological tests (California Verbal Learning Test for verbal learning, Grooved Pegboard Test for visual motoric coordination, Digit Span forward task for attention and memory, Trail-Making-Test A and B for executive function) and/or a combined z-score >1.96
Measured: preoperative psychometric evaluation on the day before surgery, postoperative psychometric evaluation between day 3 and 14 after surgery
Secondary outcomes (1)
cognitive failures three months following surgery
Self-assessment of cognitive failures using a validated questionnaire (Cognitive Failures Questionnaire). The questionnaire evaluates self-reported failures in perception, memory, and motor function. The questionnaire contains 25 items on a 5-point Likert scale. Total sum score from 0 (minimum) to 100 (maximum).
Measured: three months after elective surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start14 Apr 2016
- Primary completionApr 2020
- Study completion3 Apr 2020
Why it stopped: recruitment difficulties, high postoperative drop-out rate
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 Cognitive Function AbnormalStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Fischer, MD, PhD, Principal investigator, Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101006
- Sponsor's protocol ID
- PV4771
- Status last verified
- Aug 2020
- First submitted
- 24 Jul 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kahl U, Rademacher C, Harler U, Juilfs N, Pinnschmidt HO, Beck S, Dohrmann T, Zollner C, Fischer M. Intraoperative impaired cerebrovascular autoregulation and delayed neurocognitive recovery after major oncologic surgery: a secondary analysis of pooled data. J Clin Monit Comput. 2022 Jun;36(3):765-773. doi: 10.1007/s10877-021-00706-z. Epub 2021 Apr 15.
PubMed 33860406
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Autoregulation During Major Non-cardiac Surgery and Risk for Postoperative Cognitive Dysfunction in Elderly Patients
- ClinicalTrials.gov ID
- NCT04101006
- Acronym / sponsor ID
- PV4771
- Conditions
- Cognitive Function Abnormal, Anesthesia, Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties, high postoperative drop-out rate
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 24 Sep 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.
Cerebral blood flow is tightly regulated to ensure constant cerebral perfusion independently from systemic blood pressure fluctuations. This mechanism is termed cerebrovascular autoregulation and preserves adequate cerebral perfusion in a range between 50 and 150 mmHg of cerebral perfusion pressure. Upper and lower autoregulatory limits may vary individually. Beyond the autoregulatory range the protective autoregulatory response is lost, facilitating cerebral ischemia or hyperemia.
The cerebrovascular response may be altered during general anesthesia, through direct effects of anesthetic agents on the vascular tone, changes of arterial partial pressure of carbon dioxide or the administration of vasoactive substances. The association of perioperative impairment of cerebral autoregulation and postoperative cognitive function has been discussed controversially.
Detailed description
- continuous monitoring of cerebrovascular autoregulation using the correlation method
- based on near-infrared spectroscopy and invasive blood pressure measurement an index (COx) will be calculated
- autoregulation monitoring from anesthesia induction until emergence from anesthesia
- assessment of preoperative cognitive function during preanesthesia evaluation or on the day before surgery
- assessment of postoperative cognitive function between day 3 and 14 following surgery
- evaluation of subjective cognitive complaints or attention deficits 3 months after surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- screening of patients scheduled for preanesthesia evaluation prior to major non-cardiac/non-vascular surgery
Key inclusion criteria (5 listed)
- elective major non-cardiac/non-vascular surgery
- anticipated surgical duration >120 minutes
- age >= 60 years
- indication for invasive blood pressure measurement
- native German speaker
Key exclusion criteria (3 listed)
- history of cerebrovascular disease
- preexisting cognitive impairment
- history or presence of neurological disease
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
Postoperative change of cognitive function from baseline
Time frame: preoperative psychometric evaluation on the day before surgery, postoperative psychometric evaluation between day 3 and 14 after surgery
change of cognitive function following surgery compared with preoperative cognitive performance, defined as: z-score <-1.96/>1.96 in two or more neuropsychological tests (California Verbal Learning Test for verbal learning, Grooved Pegboard Test for visual motoric coordination, Digit Span forward task for attention and memory, Trail-Making-Test A and B for executive function) and/or a combined z-score >1.96
1 secondary outcome
cognitive failures three months following surgery
Time frame: three months after elective surgery
Results and safety
The study was stopped early (reason given: recruitment difficulties, high postoperative drop-out rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Derived from this study: PubMed 33860406Kahl U, Rademacher C, Harler U, Juilfs N, Pinnschmidt HO, Beck S, Dohrmann T, Zollner C, Fischer M. Intraoperative impaired cerebrovascular autoregulation and delayed neurocognitive recovery after major oncologic surgery: a secondary analysis of pooled data. J Clin Monit Comput. 2022 Jun;36(3):765-773. doi: 10.1007/s10877-021-00706-z. Epub 2021 Apr 15.
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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.
Marlene Fischer, MD, PhD principal investigator
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
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 Cognitive Function Abnormal and Anesthesia, run by Universitätsklinikum Hamburg-Eppendorf 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 3 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: stopped early, as of the sponsor's last update on 1 Sep 2020. 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 was stopped early (reason given: recruitment difficulties, high postoperative drop-out rate). Results are not available in the source record.
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?
Postoperative change of cognitive function from baseline (time frame: preoperative psychometric evaluation on the day before surgery, postoperative psychometric evaluation between day 3 and 14 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 NCT04101006, 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 1 Sep 2020.