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Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775343
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Marita Windpassinger M.D., Medical University of Vienna

Brief Summary:
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).

Condition or disease Intervention/treatment
Cognitive Decline Diagnostic Test: Neurocognitive Test Battery Diagnostic Test: Blood sampling

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery
Actual Study Start Date : October 6, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Group/Cohort Intervention/treatment
General Anesthesia

General anesthesia:

25 patients older than 65 years, undergoing elective eye surgery under general anesthesia.

Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative.

Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.

Diagnostic Test: Neurocognitive Test Battery
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.

Diagnostic Test: Blood sampling
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid

Local anesthesia with sedoanalgesia

25 patients older than 65 years, undergoing elective eye surgery under local anesthesia in combination with sedoanalgesia.

Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.

Diagnostic Test: Neurocognitive Test Battery
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.

Diagnostic Test: Blood sampling
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid

Control Group

25 patients, not undergoing any operative intervention. To determine a normal reference value of cognitive functions, a group of 25 individuals without an operative intervention will be recruited as a control group.

Intervention: neurocognitive testing (Neurocognitive Test Battery) at 3 determined time points (0, 6 and 24 hours)

Diagnostic Test: Neurocognitive Test Battery
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.




Primary Outcome Measures :
  1. Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: before surgery (baseline) and 24 hours after surgery ]
    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).


Secondary Outcome Measures :
  1. Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: before surgery(baseline) and 6 hours after surgery ]
    The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test. (Lehrner J., 2007)


Other Outcome Measures:
  1. Blood sampling- S100b levels [ Time Frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery ]
    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.

  2. Blood sampling- IL-6 levels [ Time Frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery ]
    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.

  3. Blood sampling- CRP levels [ Time Frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery ]
    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.

  4. Blood sampling- vitamin B12 levels [ Time Frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery ]
    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.

  5. Blood sampling- vitamin D levels [ Time Frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery ]
    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.

  6. Blood sampling- homocysteine levels [ Time Frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery ]
    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.

  7. Blood sampling- folic acid levels [ Time Frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery ]
    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.


Biospecimen Retention:   Samples With DNA
samples of blood taken before and after intervention, investigating biomarkers for cognitive impairment


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

50 patients 65 years and older without any significant mental (MMSE ≥24) or neuropsychiatric disorders scheduled for elective ocular surgery requiring general anaesthesia or sedoanalgesia will be undergoing serial cognitive assessements pre- and postoperatively over 3 time-points.

To determine a normal reference value of cognitive functions, a group of 25 participants in the same age (≥65 years)and without surgical intervention will be recruited as a control group and undergo serial cognitive assessements over 3 time-points.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775343


Contacts
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Contact: Marita Windpassinger, MD +43140400 ext 41020 marita.windpassinger@meduniwien.ac.at
Contact: Olga Plattner, Prof. +43140400 ext 41020 olga.plattner@meduniwien.ac.at

Locations
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Austria
Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Marita Windpassinger, MD    +43140400 ext 41020    marita.windpassinger@meduniwien.ac.at   
Contact: Olga Plattner, MD    +43140400 ext 41020    olga.plattner@meduniwien.ac.at   
Principal Investigator: Marita Windpassinger, MD         
Sponsors and Collaborators
Medical University of Vienna
Additional Information:
Publications:
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.

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Responsible Party: Marita Windpassinger M.D., Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03775343    
Other Study ID Numbers: 1907/2017
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marita Windpassinger M.D., Medical University of Vienna:
Anesthesia
Postoperative cognitive decline
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders