Postoperative Cognitive Dysfunction as Geriatric Syndrome

Cognitive Dysfunction Clinical Trial

Official title:

Postoperative Cognitive Dysfunction as Geriatric Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05648890
• Other study ID #: ThomasBH
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: November 22, 2023

Study information

• Verified date: November 2023
• Source: Tomas Bata Hospital, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 22, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications

Locations

Country	Name	City	State
Czechia	ThomasBH	Zlín

Sponsors (1)

Lead Sponsor	Collaborator
Tomas Bata Hospital, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test of cognitive decline before surgery for clinical practise - MMSE	MMSE test is used by administrator before and after surgery. MMSE is 30point questionnaire. Maximum score is 30 points. Score of 25 or higher is classed as normal cognitive capacity, 24 points and below is indicating possible congitive impairment, 21-23 points are light congitive impairment, 20-11 points are modern impairment, score 10 points or below indicate severe cognitive impairment.; At the end of testing before surgery administrator will access if patient has possible cognitive impairment. Later on, at the end of testing after surgery administrator will access if the results in test are different from before surgery. The data will be aggregated into 3 groups. First group are results of the test before surgery, second after. The third group is for the assessment if there is possible cognitive impairment before surgery.	2020-2023
Primary	Test of cognitive decline before surgery for clinical practise - TEGEST test	TEGEST test is used by administrator before and 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 will access if patient has possible cognitive impairment. Later on, at the end of testing after surgery administrator will access if the results in test are different from before surgery.; The data will be aggregated into 3 groups. First group are results of the test before surgery, second after. The third group is for the assessment if there is possible cognitive impairment before surgery.	2022-2023
Primary	Test of cognitive decline before surgery for clinical practise - Clock drawing test	Clock drawing test is used by administrator before and after surgery. 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.; At the end of testing before surgery administrator will access if patient has possible cognitive impairment. Later on, at the end of testing after surgery administrator will access if the results in test are different from before surgery.; The data will be aggregated into 3 groups. First group are results of the test before surgery, second after. The third group is for the assessment if there is possible cognitive impairment before surgery.	2022-2023

External Links

•   outcomes of pilot study - 2021