An interventional study of Spinal anesthesia group: bupivacaine 10-15mg and General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane in Alzheimer's Disease and Dementia, sponsored by University Health Network, Toronto. Status unknown at 3 sites in 2 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention
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.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 500 is above the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Spinal anesthesia group will receive bupivacaine 10-15mg anesthesia according to the standard practice. Supplemental sedation with intravenous anesthetics (midazolam/propofol) will be optional.
Drug: Spinal anesthesia group: bupivacaine 10-15mg · Genetic: Blood test · Other: Lumbar spinal tap · Behavioral: Montreal Cognitive Assessment (MOCA) and MMSE
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.
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
DNA will be tested for the presence of ε4 allele of the apolipoprotein E gene
1ml of cerebrospinal fluid (CSF) removed and stored for further analysis of amyloid tau protein after completion of the study
Assessing the incidence of early dementia
Time frame: Change from baseline, hospital discharge (3 day average), 3 months, 1 year, and 2 years
Ran from Mar 2014 to primary completion in Nov 2019, 68 months.
Of 806 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's 68 months is above that.
Counting every sponsor, half of 874 studies reached it within 31 months; a quarter within 15 and three quarters within 52.
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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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