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Completed

NCT Number: NCT03775343

Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery

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).

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Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age 65 and older
  • scheduled to undergo elective ocular surgery
  • American Society of Anesthesiologists class I, II or III
  • MMSE score ≥ 24
  • The people signed informed consent.
  • Expected surgical duration <90 minutes
  • Able to follow study instructions.

Exclusion criteria

  • Patients age < 65 years
  • Emergent nature of the ocular surgery
  • American Society of Anesthesiologists class IV
  • MMSE score < 24
  • unsigned informed consent
  • Expected surgical duration >90 minutes
  • Not able to follow study instructions.
  • History of psychiatric or neurologic disorders (epilepsy, trauma, stroke,depressive disorders, hemorrhage, transient ischemic attack
  • Drug or substance abuse history

Treatment and study plan

Neurocognitive Test Battery

Diagnostic Test

neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.

Blood sampling

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2018
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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