Postoperative Cognitive Dysfunction as Geriatric Syndrome

NCT ID: NCT05648890

Last Updated: 2025-02-26

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-11-22

Brief Summary

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This study is testing cognitive function before and after the surgery, with patient's informed consent. Patients of interest are 65 year or older, undergoing surgery in general or regional anesthesia.

Investigators are using 3 tests. These are: MMSE (Mini Mental State Exam), TEGEST test (test of gestures) and Clock drawing test.

Tests after surgery are performed 2 days until discharge. The testing is anonymous, patient is assigned a number. Main aim of this study is to find a suitable quick test of cognitive function for clinical practice before surgery in general or regional anesthesia.

Detailed Description

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This study is testing cognitive function before and after the surgery, with patient's informed consent. Patients of interest are 65 year or older, undergoing surgery in general or regional anesthesia.

Investigators are using 3 tests, MMSE - Mini Mental state exam, TEGEST - test of gestures and Clock drawing test with Baja scoring system.

MMSE is 30-point questionnaire. Maximum score for MMSE is 30 points. Score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. Score 21-23 indicate light cognitive impairment, score 20 - 11 indicate modern cognitive impairment, score 10 points or below indicate severe cognitive impairment.

Maximum score for TEGEST test is 6 points. Score of 4 or less indicates possible cognitive impairments. Patient is showed 6 gestures symbolizing senses (putting on glasses, smelling the flower, looking through telescope, eating with spoon, touching the cheek and picking up the telephone). After showing patient repeats 6 gestures.

Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for Clock drawing test with Baja scoring system is 5 points. Score 4 or less indicates possible cognitive impairments.

Before testing doctor is assessing Clinical frailty scale (CFS). CSF is tool that can be used to quickly and simply assess frailty. The testing takes place in anesthesiology ambulance before surgery, after operation in clinical wards.

Patients can ask anytime for their results (before or after surgery). A score from 1 (very fit) to 9 (terminally ill) is given based on the descriptions and pictographs of activity and functional status.

Tests after surgery are performed 2 days until discharge. The testing is anonymous a number is assigned to a patients. Patients can refuse anytime to participate in the testing.

The anesthesiologist performing tests is a doctor and can't participate in patient's care in the operating room.

Main aim of this study is to find a suitable quick test of cognitive function for clinical practice before surgery for patients undergoing general or regional anesthesia.

Conditions

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Cognitive Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients above 65 years old undergoing surgery in general or regional anesthesia.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age 65 or older
* absence of sensory impairment (deafness)
* full legal capacity
* informed consent
* ability to speak
* elective or acute surgical procedure

Exclusion Criteria

* somnolence, coma
* sepsis
* Glasgow coma scale 14 and less
* known psychiatric disease
* effect of premedication, drugs
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tomas Bata Hospital, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Klára Nekvindová

MUDr. Klára Nekvindová - Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ThomasBH

Zlín, , Czechia

Site Status

Countries

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Czechia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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ThomasBH

Identifier Type: -

Identifier Source: org_study_id

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