Cognitive Decline Clinical Trial
Official title:
Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery
NCT number | NCT03775343 |
Other study ID # | 1907/2017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 6, 2018 |
Est. completion date | August 30, 2023 |
Verified date | August 2023 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This project will investigate changes in cognitive function in the early postoperative phase (<24 hours) after minor surgery in patients of older age (≥65 years).
Status | Completed |
Enrollment | 75 |
Est. completion date | August 30, 2023 |
Est. primary completion date | August 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Patients age 65 and older 2. scheduled to undergo elective ocular surgery 3. American Society of Anesthesiologists class I, II or III 4. MMSE score = 24 5. The people signed informed consent. 6. Expected surgical duration <90 minutes 7. Able to follow study instructions. Exclusion Criteria: 1. Patients age < 65 years 2. Emergent nature of the ocular surgery 3. American Society of Anesthesiologists class IV 4. MMSE score < 24 5. unsigned informed consent 6. Expected surgical duration >90 minutes 7. Not able to follow study instructions. 8. History of psychiatric or neurologic disorders (epilepsy, trauma, stroke,depressive disorders, hemorrhage, transient ischemic attack 9. Drug or substance abuse history |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Foki T, Hitzl D, Pirker W, Novak K, Pusswald G, Auff E, Lehrner J. Erratum to: Assessment of individual cognitive changes after deep brain stimulation surgery in Parkinson's disease using the Neuropsychological Test Battery Vienna short version. Wien Klin Wochenschr. 2017 Aug;129(15-16):585-587. doi: 10.1007/s00508-017-1210-2. No abstract available. — View Citation
Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood sampling- S100b levels | Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of S100-B protein (µg/L) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery. | before surgery, at the end point of surgery, 6 and 24 hours after surgery | |
Other | Blood sampling- IL-6 levels | Blood sampling will be taken at all patients scheduled for elective ocular surgery. Serum levels of interleukin-6 type cytokines (IL-6 (pg/mL)) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery. | before surgery, at the end point of surgery, 6 and 24 hours after surgery | |
Other | Blood sampling- CRP levels | Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of C-Reactive Protein (CRP) (mg/L)will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery. | before surgery, at the end point of surgery, 6 and 24 hours after surgery | |
Other | Blood sampling- vitamin B12 levels | Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of vitamin B12 (pg/mL) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery. | before surgery, at the end point of surgery, 6 and 24 hours after surgery | |
Other | Blood sampling- vitamin D levels | Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of vitamin D (ng/ml) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery. | before surgery, at the end point of surgery, 6 and 24 hours after surgery | |
Other | Blood sampling- homocysteine levels | Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of homocysteine (mcmol/L)will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery. | before surgery, at the end point of surgery, 6 and 24 hours after surgery | |
Other | Blood sampling- folic acid levels | Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of folic acid (µg/L) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery. | before surgery, at the end point of surgery, 6 and 24 hours after surgery | |
Primary | Neuropsychological Test Battery Vienna (NTBV) | The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test to assess a broad range of cognitive abilities.(Lehrner J., 2007) It was created to detect cognitive impairment in Alzheimer's Disease (Lehrner J., 2007). The investigators will investigate changes in NTBV between baseline compared to 24 hour after minor surgery using regression based z-score analyses (-1,5 - + 1,5 standard deviation(SD) ; > -1,5 SD indicating a larger decline in cognitive function). | before surgery (baseline) and 24 hours after surgery | |
Secondary | Neuropsychological Test Battery Vienna (NTBV) | The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test. (Lehrner J., 2007) | before surgery(baseline) and 6 hours after surgery |
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