drugset / Trial / NCT01903421

Inhalational Anesthesia and Precipitation of Dementia: is There a Link?

NCT01903421

Unknown 500 enrolled University Health Network, Toronto
RandomizedParallel-groupOpen-labelPrevention

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. 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.

Timeline

Start
2014-03
Primary completion
2019-11
Completion
2023-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 10 mg Other
Comparator Bupivacaine Other / unclassified 15 mg Other
Comparator Isoflurane Other / unclassified Inhaled
Comparator Sevoflurane Other / unclassified Inhaled
Comparator Fentanyl Other / unclassified 1 g/kg
Comparator Fentanyl Other / unclassified 3 g/kg
Comparator Propofol Small molecule 1.5 mg/kg
Comparator Propofol Small molecule 2 mg/kg

Indications