Alzheimer's DiseaseNCT01903421
Inhalational Anesthesia and Precipitation of Dementia: is There a Link?
A study testing Spinal anesthesia group: bupivacaine 10-15mg, General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane and Blood test in people with Alzheimer's Disease and Dementia, run by University Health Network, Toronto at 3 sites in 2 countries.
Trial summary
Many elderly patients undergoing surgical procedures already have impaired cognitive (memory/concentration) status. Patients with pre-existing cognitive impairment, or dementia, may benefit from modified anesthesia techniques. It is estimated that one in eight people age 65 and older has Alzheimers disease. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Spinal anesthesia group: bupivacaine 10-15mg, General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane and Blood test
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2014to Jul 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >65 yrs of age
- Male or female
- Scheduled to undergo urologic procedures (e.g., transurethral resection of prostate, transurethral resection of bladder tumor), orthopedic (e.g., total knee replacement, total hip replacement) general (e.g., femoral hernia repair, lower abdominal surgery) or vascular surgery procedures (e.g. lower limb reperfusion amputations) and qualifies to be randomized to receive either local (spinal) or general anesthetic
Who cannot join
- Diagnosis of severe dementia
- Diagnosis of any other significant neurological disease such as Parkinson's, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain or spinal abnormalities.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
William Osler Health Centre
Toronto, Ontario, M9V 1R8
About this study
Official title: Inhalational Anesthesia and Precipitation of Dementia: is There a Link? A Prospective, Multicenter, Randomized, Controlled Clinical Trial Comparing Two Different Anesthetic Techniques in Elderly Patients
Many elderly patients undergoing surgical procedures already have impaired cognitive (memory/concentration) status. Patients with pre-existing cognitive impairment, or dementia, may benefit from modified anesthesia techniques. It is estimated that one in eight people age 65 and older has Alzheimers disease. More so, nearly half of people that are 85 years or older have Alzheimers disease. Currently, both spinal (regional) and inhalational (general) anesthesia, are used in patients undergoing common urological, orthopedic, and general surgical procedures. Inhalational anesthesia has been associated with higher risk of memory impairment in experimental (animal) and human studies. However, currently, there are simply no large or good enough studies to be sure that inhalational anesthesia is responsible for causing dementia and Alzheimers disease.The proposed study investigates if elderly patients (65 years and older) undergoing spinal anesthesia (patient is awake or slightly sedated) are less likely to develop dementia and Alzheimers disease for up to 2 years after surgery, when compared to inhalational anesthesia (patient is kept asleep with gas anesthetic). The investigators will also test all patients for the presence of apolipoprotein (ApoE-Îμ4 type of gene that is present in 15-20% of patients), and beta-amyloid tau protein (present in cerebrospinal fluid) that are known risk factors for Alzheimers disease. The particular strength of this study is that it takes into account whether the frequency and/or severity of dementia and Alzheimers disease is different in patients with and without these markers. The investigators believe that this study will make a major contribution to better understanding of development of Alzheimers disease.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Spinal anesthesia group: bupivacaine 10-15mg, General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane, Blood test, Lumbar spinal tap, Montreal Cognitive Assessment (MOCA) and MMSE
- Keywords
- Elderly surgical patients, Alzheimer's disease, Dementia, Elderly, Surgery
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia group: bupivacaine 10-15mgDrug
General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevofluraneDrug
Blood testGenetic
DNA will be tested for the presence of ε4 allele of the apolipoprotein E gene
Lumbar spinal tapOther
1ml of cerebrospinal fluid (CSF) removed and stored for further analysis of amyloid tau protein after completion of the study
Montreal Cognitive Assessment (MOCA) and MMSEBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia group | Active comparator | Spinal anesthesia group will receive bupivacaine 10-15mg anesthesia according to the standard practice. Supplemental sedation with intravenous anesthetics (midazolam/propofol) will be optional. Receives: Drug: Spinal anesthesia group: bupivacaine 10-15mg; Genetic: Blood test; Other: Lumbar spinal tap; Behavioral: Montreal Cognitive Assessment (MOCA) and MMSE |
| General anesthesia group | Active comparator | Induction of anesthesia will be achieved with propofol 1.5-2mg/kg and fentanyl 1-3g/kg. Anesthesia will be maintained with inhalational anesthesia (isoflurane or sevoflurane) at the discretion of anesthesiologist in charge of the case. A mixture of Air/O2 will be used to maintain adequate oxygenation. Nitrous oxide will not be used. Receives: Drug: General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane; Genetic: Blood test; Other: Lumbar spinal tap; Behavioral: Montreal Cognitive Assessment (MOCA) and MMSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the incidence of early dementia
Measured: Change from baseline, hospital discharge (3 day average), 3 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMar 2014
- Primary completionNov 2019
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study will be a prospective, multicenter, cluster randomization clinical trial comparing two different anesthetic techniques in elderly patients (\> 65 years of age) undergoing urology/orthopedic/general surgery. The study will follow a cluster design; patients undergoing orthopedic or vascular surgery will have spinal anesthesia, where standard practice. Patients undergoing urology or general surgery will receive general anesthesia, also where it is standard practice. Patients with severe dementia will be excluded.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Djaiani, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903421
- Sponsor's protocol ID
- 13-6122
- Status last verified
- Dec 2022
- First submitted
- 11 Jul 2013
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalational Anesthesia and Precipitation of Dementia: is There a Link? A Prospective, Multicenter, Randomized, Controlled Clinical Trial Comparing Two Different Anesthetic Techniques in Elderly Patients
- ClinicalTrials.gov ID
- NCT01903421
- Acronym / sponsor ID
- 13-6122
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Elderly surgical patients, Alzheimer's disease, Dementia, Elderly, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jul 2023 (estimated)
- First posted
- 19 Jul 2013 (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.
Many elderly patients undergoing surgical procedures already have impaired cognitive (memory/concentration) status. Patients with pre-existing cognitive impairment, or dementia, may benefit from modified anesthesia techniques. It is estimated that one in eight people age 65 and older has Alzheimers disease. More so, nearly half of people that are 85 years or older have Alzheimers disease. Currently, both spinal (regional) and inhalational (general) anesthesia, are used in patients undergoing common urological, orthopedic, and general surgical procedures. Inhalational anesthesia has been associated with higher risk of memory impairment in experimental (animal) and human studies. However, currently, there are simply no large or good enough studies to be sure that inhalational anesthesia is responsible for causing dementia and Alzheimers disease.The proposed study investigates if elderly patients (65 years and older) undergoing spinal anesthesia (patient is awake or slightly sedated) are less likely to develop dementia and Alzheimers disease for up to 2 years after surgery, when compared to inhalational anesthesia (patient is kept asleep with gas anesthetic). The investigators will also test all patients for the presence of apolipoprotein (ApoE-Îμ4 type of gene that is present in 15-20% of patients), and beta-amyloid tau protein (present in cerebrospinal fluid) that are known risk factors for Alzheimers disease. The particular strength of this study is that it takes into account whether the frequency and/or severity of dementia and Alzheimers disease is different in patients with and without these markers. The investigators believe that this study will make a major contribution to better understanding of development of Alzheimers disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study will be a prospective, multicenter, cluster randomization clinical trial comparing two different anesthetic techniques in elderly patients (> 65 years of age) undergoing urology/orthopedic/general surgery. The study will follow a cluster design; patients undergoing orthopedic or vascular surgery will have spinal anesthesia, where standard practice. Patients undergoing urology or general surgery will receive general anesthesia, also where it is standard practice. Patients with severe dementia will be excluded.
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia group | Active comparator | Drug: Spinal anesthesia group: bupivacaine 10-15mg, Genetic: Blood test, Other: Lumbar spinal tap, Behavioral: Montreal Cognitive Assessment (MOCA) and MMSESpinal anesthesia group will receive bupivacaine 10-15mg anesthesia according to the standard practice. Supplemental sedation with intravenous anesthetics (midazolam/propofol) will be optional. |
| General anesthesia group | Active comparator | Drug: General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane, Genetic: Blood test, Other: Lumbar spinal tap, Behavioral: Montreal Cognitive Assessment (MOCA) and MMSEInduction of anesthesia will be achieved with propofol 1.5-2mg/kg and fentanyl 1-3g/kg. Anesthesia will be maintained with inhalational anesthesia (isoflurane or sevoflurane) at the discretion of anesthesiologist in charge of the case. A mixture of Air/O2 will be used to maintain adequate oxygenation. Nitrous oxide will not be used. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- >65 yrs of age
- Male or female
- Scheduled to undergo urologic procedures (e.g., transurethral resection of prostate, transurethral resection of bladder tumor), orthopedic (e.g., total knee replacement, total hip replacement) general (e.g., femoral hernia repair, lower abdominal surgery) or vascular surgery procedures (e.g. lower limb reperfusion amputations) and qualifies to be randomized to receive either local (spinal) or general anesthetic
Key exclusion criteria (2 listed)
- Diagnosis of severe dementia
- Diagnosis of any other significant neurological disease such as Parkinson's, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain or spinal abnormalities.
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 |
|---|---|---|
| Spinal anesthesia group: bupivacaine 10-15mg | Drug | Spinal anesthesia group |
| General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane | Drug | General anesthesia group |
| Blood testDNA will be tested for the presence of ε4 allele of the apolipoprotein E gene | Genetic | General anesthesia group, Spinal anesthesia group |
| Lumbar spinal tap1ml of cerebrospinal fluid (CSF) removed and stored for further analysis of amyloid tau protein after completion of the study | Other | General anesthesia group, Spinal anesthesia group |
| Montreal Cognitive Assessment (MOCA) and MMSE | Behavioural | General anesthesia group, Spinal anesthesia group |
Primary outcome
Assessing the incidence of early dementia
Time frame: Change from baseline, hospital discharge (3 day average), 3 months, 1 year, and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 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.
George Djaiani, MD principal investigator
Toronto General Hospital, University Health Network
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia group: bupivacaine 10-15mg, General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane and Blood test in people with Alzheimer's Disease and Dementia, run by University Health Network, Toronto at 3 sites in 2 countries.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Latvia. 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?
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?
Assessing the incidence of early dementia (time frame: Change from baseline, hospital discharge (3 day average), 3 months, 1 year, and 2 years). 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 5 Dec 2022.