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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01903421
• Other study ID #: 13-6122
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 2023

Study information

• Verified date: December 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 2023
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• >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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• 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

Genetic:
• Blood test
DNA will be tested for the presence of e4 allele of the apolipoprotein E gene

Other:
• Lumbar spinal tap
1ml of cerebrospinal fluid (CSF) removed and stored for further analysis of amyloid tau protein after completion of the study

Behavioral:
• Montreal Cognitive Assessment (MOCA) and MMSE

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario
Canada	William Osler Health Centre	Toronto	Ontario
Latvia	Pauls Stradins Clinical University Hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Countries where clinical trial is conducted

Canada,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the incidence of early dementia		Change from baseline, hospital discharge (3 day average), 3 months, 1 year, and 2 years