Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery

Completed

• Conditions: Cognitive Decline
• Interventions: Diagnostic Test: Neurocognitive Test Battery; Diagnostic Test: Blood sampling

• Registration Number: NCT03775343
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2018-10-06
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-13
• Status Verified: 2023-08
• Primary Completion: 2023-08-28
• Last Update Submitted: 2023-08-29
• Study Completion: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General Anesthesia	Neurocognitive Test Battery	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.
Control Group	Neurocognitive Test Battery	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)
Local anesthesia with sedoanalgesia	Neurocognitive Test Battery	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.
Local anesthesia with sedoanalgesia	Blood sampling	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.
General Anesthesia	Blood sampling	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.

Primary Outcome Measures

Name	Time	Method
Neuropsychological Test Battery Vienna (NTBV)	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

Name	Time	Method
Neuropsychological Test Battery Vienna (NTBV)	before surgery(baseline) and 6 hours after surgery	The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test. (Lehrner J., 2007)

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria