Clinical trial NCT03775343: Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery
Official title: Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Decline
Keywords: Anesthesia
Postoperative cognitive decline
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Neuropsychological Test Battery Vienna (NTBV)
timeFrame: before surgery (baseline) and 24 hours after surgery
Secondary outcomes:
measure: Neuropsychological Test Battery Vienna (NTBV)
timeFrame: before surgery(baseline) and 6 hours after surgery
Other outcomes:
measure: Blood sampling- S100b levels
timeFrame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
measure: Blood sampling- IL-6 levels
timeFrame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
measure: Blood sampling- CRP levels
timeFrame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
measure: Blood sampling- vitamin B12 levels
timeFrame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
measure: Blood sampling- vitamin D levels
timeFrame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
measure: Blood sampling- homocysteine levels
timeFrame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
measure: Blood sampling- folic acid levels
timeFrame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References:
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.
citation: 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.