AnesthesiaBIS & DementiaNCT02382445
Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction
A study testing Anesthesia depth monitor and propofol and sevoflurane in people with Anesthesia and Delirium, run by Heidelberg University at 1 site in Germany.
Trial summary
Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Anesthesia, Delirium, Dementia
- What is being tested?
- Anesthesia depth monitor and propofol and sevoflurane
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to 8 May 2017
- Phase
- Interventional
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults older than 70 years
- major surgery ( spine, orthopedic, urologic, gynecology, abdominal)
Who cannot join
- adults younger than 71 years
- major blood loss surgery
- allergy to soja oil, nuts, other ingredients of propofol
- patient wants to have spinal or regional anesthesia only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs
Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. The amount of those markers seems to correlate well with the degree of dementia [1]. In contradiction, a single study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to POCD and dementia. Another possibility is that stress and noxious stimulation induced by light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit memory.
The investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period.
The investigators' hypothesis is that the incidence of POCD and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the BIS- guided anesthesia group with the superficial but sufficient anesthesia level.
- Conditions
- Anesthesia, Delirium, Dementia, Bispectral Index Monitor
- Being tested
- Anesthesia depth monitor, Sham control, propofol and sevoflurane
- Medical subject headings
- Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia depth monitorDevice
Also called Aim at an anesthesia level of BIS 50-60 titrating propofol and sevoflurane in the experimental
Sham controlDevice
Standard care as usual. Bis m Standard care as usual. Bispectral index monitor is not visible for anesthesia provider.
propofol and sevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia depth monitor | Experimental | Anesthesia depth is aimed to be between BIS 50-60 Receives: Device: Anesthesia depth monitor; Drug: propofol and sevoflurane |
| Control group | Sham comparator | Anesthesia depth is monitored but blinded to the anesthesiologist Receives: Device: Sham control; Drug: propofol and sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognition and mental capacity of elderlies following major surgery
Mini Mental State Test (MMSE) and automated Memory and Attention Test (MAT) were performed on the day before and after the surgery. The MAT is a validated computerized test for the discrimination of short and long time memory, for visual and auditory comprehension and attention capacity.
Measured: One day after surgery
Secondary outcomes (1)
Incidence of mental and other complications (serious adverse events)
Incidences of delirium and mental dysfunction until hospital discharge is counted. Delirium was postoperatively diagnosed by the NUDESC, postoperative cognitive dysfunction (POCD) by the MAT, other serious adverse events in the course of the hospital stay were noted.
Measured: 90 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJan 2014
- Primary completion8 May 2017
- Study completion8 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Frietsch, Universitätsmedizin Mannheim
- Investigators
- Thomas Frietsch, Prof, MD, Study director, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382445
- Sponsor's protocol ID
- BIS-Diako-Ma-2014
- Acronym
- BIS & Dementia
- Status last verified
- May 2022
- First submitted
- 11 Aug 2014
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs
- ClinicalTrials.gov ID
- NCT02382445
- Acronym / sponsor ID
- BIS & Dementia / BIS-Diako-Ma-2014
- Conditions
- Anesthesia, Delirium, Dementia, Bispectral Index Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 8 May 2017 (actual)
- First posted
- 6 Mar 2015 (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.
Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. The amount of those markers seems to correlate well with the degree of dementia [1]. In contradiction, a single study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to POCD and dementia. Another possibility is that stress and noxious stimulation induced by light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit memory.
The investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period.
The investigators' hypothesis is that the incidence of POCD and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the BIS- guided anesthesia group with the superficial but sufficient anesthesia level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesia depth monitor | Experimental | Device: Anesthesia depth monitor, Drug: propofol and sevofluraneAnesthesia depth is aimed to be between BIS 50-60 |
| Control group | Sham comparator | Device: Sham control, Drug: propofol and sevofluraneAnesthesia depth is monitored but blinded to the anesthesiologist |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults older than 70 years
- major surgery ( spine, orthopedic, urologic, gynecology, abdominal)
Key exclusion criteria (4 listed)
- adults younger than 71 years
- major blood loss surgery
- allergy to soja oil, nuts, other ingredients of propofol
- patient wants to have spinal or regional anesthesia only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia depth monitorAlso: Aim at an anesthesia level of BIS 50-60 titrating propofol and sevoflurane in the experimental | Device | Anesthesia depth monitor |
| Sham controlStandard care as usual. Bis m Standard care as usual. Bispectral index monitor is not visible for anesthesia provider. | Device | Control group |
| propofol and sevoflurane | Drug | Anesthesia depth monitor, Control group |
Primary outcome
Postoperative cognition and mental capacity of elderlies following major surgery
Time frame: One day after surgery
Mini Mental State Test (MMSE) and automated Memory and Attention Test (MAT) were performed on the day before and after the surgery. The MAT is a validated computerized test for the discrimination of short and long time memory, for visual and auditory comprehension and attention capacity.
1 secondary outcome
Incidence of mental and other complications (serious adverse events)
Time frame: 90 postoperative days
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 24 May 2022.
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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.
Thomas Frietsch, Prof, MD study director
Universitätsmedizin Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia depth monitor and propofol and sevoflurane in people with Anesthesia and Delirium, run by Heidelberg University 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 2 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 24 May 2022. 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. Some participants in this study may receive a placebo. 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?
Postoperative cognition and mental capacity of elderlies following major surgery (time frame: One day after surgery). 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 24 May 2022.