Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery

Cognitive Decline Clinical Trial

Official title:

Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775343
• Other study ID #: 1907/2017
• Status: Completed
• Start date: October 6, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Primary aim of this study is to evaluate changes in cognitive function in the early postoperative phase after minor surgery in patients of older age (≥65 years).

Background: Postoperative cognitive dysfunction can be a serious complication after surgery and is associated with higher mortality.Several studies have demonstrated that major surgery and patients of older age are risk factors for the incidence of cognitive decline in the postoperative phase. Only a few studies investigated the early postoperative changes in cognitive function (< 24 hours) after minor, day case surgeries in older patients (≥65 years), demonstrating a higher incidence than observed ≥1 week after surgery.

Aim of the project: This study aimed to investigate changes in cognitive function after minor surgery in an elderly patient cohort.

It is the effort to plan perioperative care that can reduce the incidence of postoperative cognitive dysfunction in elderly.

Hypothesis: The present study support the hypothesis that changes in cognitive function after ocular surgery will be greater in the general anesthesia group compared to the sedoanalgesia group.

Methods:

The study will be conducted as a single center, prospective, observational controlled trial at the Medical University of Vienna, Austria.

This prospective and observational study involves consecutive elderly patients (≥65 years) undergoing a minor surgery using general anesthesia or local anesthesia with sedoanalgesia. Fifty patients, 65 years and older, scheduled for elective minor ocular surgery and 25 participants as control group without surgical intervention will be recruited.

Enrollees will be divided in 3 groups:

25 patients general anaesthesia (GA), 25 patients sedoanalgesia combined with local anaesthesia (SA) and 25 participants as control group(CO) without surgical intervention.

Anesthesia will be induced in a standardized fashion in both groups (GA,SA). At baseline the performance on neurocognitive testing using the Mini Mental State Examination (MMSE) hast to be ≥24, otherwise participants will be excluded.

The design utilizes prospective serial assessments of cognitive status. The participants will be evaluated preoperatively and postoperatively over 3 time-points (preoperatively, 6 and 24 hours after surgery) using the Neurocognitive Test Battery Vienna (NTBV) for cognitive assessment.

At the same time points blood tests for plasma levels of S 100-B, IL-6, CRP, vitamin B 12, vitamin D, homocysteine and folic acid will be taken.

This project will investigate the correlation between perioperative changes in these serum parameters with neurocognitive outcome in the elderly after minor surgery to explore whether the concentrations of these parameters can be used as predictors of postoperative cognitive dysfunction and to provide reference for postoperative cognitive dysfunction prevention, early detection and timely diagnosis and treatment.

Further purpose of this study is to investigate if there is an association between changes in intraoperative cerebral oxygenation, changes in perioperative blood pressure, depth of anaesthesia and the presence of cognitive deterioration after surgery.

It is the effort to plan perioperative care that can reduce the incidence of postoperative changes in cognitive function.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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.

Outcome

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