Cognitive DysfunctionNCT00719628
Depth of Anaesthesia and Cognitive Dysfunction
An observational study of Cognitive Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if there is an association between the depth of anaesthesia and the presence of cognitive deterioration after surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2008to Apr 2009
- 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: Patients above 60 years eligible for surgery
Who may be able to join
- Age above 60
- Surgery in general anesthesia
- surgery > 1 hour
- ASA: 1-3
Who cannot join
- Dementia
- Excessive Use of alcohol or anxiolytics
- Unable to understand danish
- MMSE score < 24
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Depth of Anaesthesia and Presence of Postoperative Cognitive Dysfunction
The purpose of this study is to investigate if there is an association between the depth of anaesthesia and the presence of cognitive deterioration after surgery.
- Conditions
- Cognitive Dysfunction
- Keywords
- Postoperative, Cognitive, Dysfunction
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
mean Cerebral state index in relation to postoperative cognitive dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Lars S Rasmussen, MD, PhD, Study director, Dep anaesthesia, HOC, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719628
- Sponsor's protocol ID
- JAS-001
- Status last verified
- Apr 2009
- First submitted
- 21 Jul 2008
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depth of Anaesthesia and Presence of Postoperative Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT00719628
- Acronym / sponsor ID
- JAS-001
- Conditions
- Cognitive Dysfunction
- Keywords
- Postoperative, Cognitive, Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Jul 2008 (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.
The purpose of this study is to investigate if there is an association between the depth of anaesthesia and the presence of cognitive deterioration 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
- Patients above 60 years eligible for surgery
Key inclusion criteria (4 listed)
- Age above 60
- Surgery in general anesthesia
- surgery > 1 hour
- ASA: 1-3
Key exclusion criteria (4 listed)
- Dementia
- Excessive Use of alcohol or anxiolytics
- Unable to understand danish
- MMSE score < 24
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
mean Cerebral state index in relation to postoperative cognitive dysfunction
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 7 Apr 2009.
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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.
Lars S Rasmussen, MD, PhD study director
Dep anaesthesia, HOC, Rigshospitalet
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 Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 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 7 Apr 2009. 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 Denmark. 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?
mean Cerebral state index in relation to postoperative cognitive dysfunction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2009.