Cognitive DysfunctionNCT05648890

Postoperative Cognitive Dysfunction as Geriatric Syndrome

An observational study of Cognitive Dysfunction, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Cognitive Dysfunction
How many people: 203 participants
Where: 1 siteCzechia
Study dates: 1 Oct 2020to 22 Nov 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Study population: Patients 65 years old and older undergoing surgical procedure in general or regional anesthesia or analgosedation.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

ThomasBH
Zlín, 76001

Other trials in Czechia

About this study

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.

Read the detailed description

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: Cognitive Dysfunction
Keywords: anesthesia, elderly people, PND, POCD, surgery
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05648890
Study group	Role	What they receive
Group 1		Patients above 65 years old undergoing surgery in general or regional anesthesia.

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Cognitive Dysfunction - Results of MMSE Before Operation
MMSE test was used by administrator before surgery. MMSE is 30 point questionnaire. Maximum score is 30 points. Score of 25 or higher is classed as normal cognitive capacity, 24 points and below is indicating possible congnitive impairment, 21-23 points are light cognitive impairment, 20-11 points are modern impairment, score 10 points or below indicate severe cognitive impairment. The test took 10 minutes approximately.
Measured: 2 days before operation
Postoperative Cognitive Dysfunction - Results of MMSE After Operation
MMSE test was used by administrator after surgery. MMSE is 30 point questionnaire. Score 25 or higher is know as normal cognitive capacity. Score 24 and below is indicating possible cognitive impairment, score 23-21 points are light cognitive impairment, 20-11 points are mild cognitive impairment, score 10 point or below indicate severe cognitive impairment. The test took 10 minutes approximately.
Measured: 3rd day after operation
Postoperative Cognitive Dysfunction - TEGEST Test Before Operation
TEGEST test is used by administrator before surgery. 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 the patient repeats 6 gestures. Maximum score is 6 points, score of 4 or less indicates possible cognitive impairments.
At the end of testing before surgery administrator did access if patient has possible cognitive impairment. The test took 3 minutes.
Measured: 2 days before operation
Postoperative Cognitive Dysfunction - TEGEST Test After Operation
TEGEST test is used by administrator after surgery. 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 the patient repeats 6 gestures. Maximum score is 6 points, score of 4 or less indicates possible cognitive impairments.
At the end of testing before surgery administrator did access if patient has possible cognitive impairment. The test took 3 minutes.
Measured: 3rd day after operation
Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation
Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time given by administrator, which is 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for is 5 points. Score 4 or less indicates possible cognitive impairment. The test took 3 minutes.
Measured: 2 days before operation
Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation
Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time given by administrator, which is 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for is 5 points. Score 4 or less indicates possible cognitive impairment. The test took 3 minutes.
Measured: 3rd day after operation

Secondary outcomes (4)

Clinical Frailty Scale Before Operation
Measure Description: The Clinical Frailty Scale (version 2, by Rockwood) was used preoperatively to assess functional reserve of the patients.
1= very fit 2 = fit 3 = managing well 4 = living with very mild frailty 5 = living with mild frailty 6= living with moderate frailty 7= living with severe frailty 8= living with very severe frailty 9= terminally ill
Measured: 2 days before operation
Social Anamnesis Before Operation- Type of Accommodation
Type of accommodation was assessed before operation, options were: house, apartment or institutional accommodation
Measured: 2 days before operation
Social Anamnesis During Preanesthesia Exam - Living Situation
Living situation of the patients was assessed before operation. Options were living alone or living with someone (family member)
Measured: 2 days before operation
Social Anamnesis - Stairs or Elevator
Respondents living at home with stairs and respondents living at home with an elevator
Measured: 2nd day before operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202022 Nov 2023

First posted13 Dec 2022
Study start1 Oct 2020
Primary completion30 Mar 2023
Study completion22 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05648890
Sponsor's protocol ID: ThomasBH
Status last verified: Feb 2025
First submitted: 16 Nov 2022
Last updated: 26 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Nekvindova K, Ivanova K, Jurickova L, Gabrhelik T. TEGEST as promising tool for assessing the risk of perioperative neurocognitive disorders. BMC Geriatr. 2024 Aug 28;24(1):713. doi: 10.1186/s12877-024-05302-9.
PubMed 39198728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postoperative Cognitive Dysfunction as Geriatric Syndrome
ClinicalTrials.gov ID: NCT05648890
Acronym / sponsor ID: ThomasBH
Conditions: Cognitive Dysfunction
Keywords: anesthesia, elderly people, PND, POCD, surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
Study start: 1 Oct 2020 (actual)
Primary completion: 30 Mar 2023 (actual)
Study completion: 22 Nov 2023 (actual)
First posted: 13 Dec 2022 (actual)
Results: Posted 26 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

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.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Group 1	–	–Patients above 65 years old undergoing surgery in general or regional anesthesia.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult
Study population: Patients 65 years old and older undergoing surgical procedure in general or regional anesthesia or analgosedation.

Key inclusion criteria (6 listed)

age 65 or older
absence of sensory impairment (deafness)
full legal capacity
informed consent
ability to speak

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Postoperative Cognitive Dysfunction - Results of MMSE Before Operation
Time frame: 2 days before operation
MMSE test was used by administrator before surgery. MMSE is 30 point questionnaire. Maximum score is 30 points. Score of 25 or higher is classed as normal cognitive capacity, 24 points and below is indicating possible congnitive impairment, 21-23 points are light cognitive impairment, 20-11 points are modern impairment, score 10 points or below indicate severe cognitive impairment. The test took 10 minutes approximately.
Postoperative Cognitive Dysfunction - Results of MMSE After Operation
Time frame: 3rd day after operation
MMSE test was used by administrator after surgery. MMSE is 30 point questionnaire. Score 25 or higher is know as normal cognitive capacity. Score 24 and below is indicating possible cognitive impairment, score 23-21 points are light cognitive impairment, 20-11 points are mild cognitive impairment, score 10 point or below indicate severe cognitive impairment. The test took 10 minutes approximately.
Postoperative Cognitive Dysfunction - TEGEST Test Before Operation
Time frame: 2 days before operation
TEGEST test is used by administrator before surgery. 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 the patient repeats 6 gestures. Maximum score is 6 points, score of 4 or less indicates possible cognitive impairments. At the end of testing before surgery administrator did access if patient has possible cognitive impairment. The test took 3 minutes.
Postoperative Cognitive Dysfunction - TEGEST Test After Operation
Time frame: 3rd day after operation
TEGEST test is used by administrator after surgery. 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 the patient repeats 6 gestures. Maximum score is 6 points, score of 4 or less indicates possible cognitive impairments. At the end of testing before surgery administrator did access if patient has possible cognitive impairment. The test took 3 minutes.
Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation
Time frame: 2 days before operation
Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time given by administrator, which is 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for is 5 points. Score 4 or less indicates possible cognitive impairment. The test took 3 minutes.
Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation
Time frame: 3rd day after operation
Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time given by administrator, which is 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for is 5 points. Score 4 or less indicates possible cognitive impairment. The test took 3 minutes.

4 secondary outcomes

Clinical Frailty Scale Before Operation
Time frame: 2 days before operation
Social Anamnesis Before Operation- Type of Accommodation
Time frame: 2 days before operation
Social Anamnesis During Preanesthesia Exam - Living Situation
Time frame: 2 days before operation
Social Anamnesis - Stairs or Elevator
Time frame: 2nd day before operation

Results and safety

Results posted to the registry on 26 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Postoperative Cognitive Dysfunction	203	164

Primary outcome: Postoperative Cognitive Dysfunction - Results of MMSE Before Operation

Time frame: 2 days before operation. Count of participants. Unit: Participants

Measure	Results of MMSE n = 164
normal cognitive capacity before operation	79
light cognitive impairment before operation	43
modern impairment before operation	37
severe cognitive impairment before operation	5

Results of MMSE: p <0.0001, Spearman's rank correlation coefficient

Population analysed: Results of MMSE before operation, descriptive statistics.

Primary outcome: Postoperative Cognitive Dysfunction - Results of MMSE After Operation

Time frame: 3rd day after operation. Count of participants. Unit: Participants

Measure	Postoperative Cognitive Dysfunction n = 164
normal cognitive capacity	77
light cognitive impairment	43
modern impairment	38
severe cognitive impairment	6

Postoperative Cognitive Dysfunction: p < .001, Spearman's ran correlation coefficient

Primary outcome: Postoperative Cognitive Dysfunction - TEGEST Test Before Operation

Time frame: 2 days before operation. Count of participants. Unit: Participants

Measure	TEGEST TEST n = 164
normal cognition	40
impairment	124

TEGEST TEST: p <0.0001, Spearman's rank correlation coefficient

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

Primary outcome: Postoperative Cognitive Dysfunction - TEGEST Test After Operation

Time frame: 3rd day after operation. Count of participants. Unit: Participants

Measure	Postoperative Cognitive Dysfunction n = 164
normal cognition	77
cognitive impairment	87

Postoperative Cognitive Dysfunction: p <0.001, Spearman's rank correlation coefficient

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Postoperative Cognitive Dysfunction.	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Selection bias was due to the way in which patients were enrolled in the study as part of the pre-anaesthetic examination. The first information about possible cognitive impairment was given to the patients during the pre-anaesthetic examination. This information may have caused patients to feel stressed, anxious or worried, and thus may have influenced the test results. The population was limited by patient selection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39198728Nekvindova K, Ivanova K, Jurickova L, Gabrhelik T. TEGEST as promising tool for assessing the risk of perioperative neurocognitive disorders. BMC Geriatr. 2024 Aug 28;24(1):713. doi: 10.1186/s12877-024-05302-9.
outcomes of pilot study - 2021Link provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Dysfunction, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Cognitive Dysfunction - Results of MMSE Before Operation (time frame: 2 days before operation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05648890, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.