Clinical trial NCT05648890: Postoperative Cognitive Dysfunction as Geriatric Syndrome
Official title: Postoperative Cognitive Dysfunction as Geriatric Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Dysfunction
Keywords: anesthesia, elderly people
PND
POCD
surgery
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 203
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 65 years old and older undergoing surgical procedure in general or regional anesthesia or analgosedation.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Cognitive Dysfunction - Results of MMSE Before Operation
timeFrame: 2 days before operation
measure: Postoperative Cognitive Dysfunction - Results of MMSE After Operation
timeFrame: 3rd day after operation
measure: Postoperative Cognitive Dysfunction - TEGEST Test Before Operation
timeFrame: 2 days before operation
measure: Postoperative Cognitive Dysfunction - TEGEST Test After Operation
timeFrame: 3rd day after operation
measure: Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation
timeFrame: 2 days before operation
measure: Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation
timeFrame: 3rd day after operation
Secondary outcomes:
measure: Clinical Frailty Scale Before Operation
timeFrame: 2 days before operation
measure: Social Anamnesis Before Operation- Type of Accommodation
timeFrame: 2 days before operation
measure: Social Anamnesis During Preanesthesia Exam - Living Situation
timeFrame: 2 days before operation
measure: Social Anamnesis - Stairs or Elevator
timeFrame: 2nd day before operation
Other outcomes:
Locations:
city: Zlín
country: Czechia
facility: ThomasBH
Study officials:
References: