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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients above 65 years old undergoing surgery in general or regional anesthesia. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 65 years old and older undergoing surgical procedure in general or regional anesthesia or analgosedation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ThomasBH | ZlÃn | 76001 | Czechia |
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| Label | URL |
|---|---|
| outcomes of pilot study - 2021 | View source |
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A total of 203 patients participated in the study. A total of 322 potential patients were approached, 268 were screened, 58 were excluded, and 210 were suitable for testing. There were 203 patients who agreed to be included in the study, 39 patients were excluded . The study was completed by 164 patients, whose results were analysed.
All participants were selected by two doctors, main administrator and the colleague. The decision to ask patient about possible enrolment was made 24 hours before preoperative anaesthesiology exam with evaluating online organizer of anaesthesiology outpatient clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Postoperative Cognitive Dysfunction | Patients above 65 years old undergoing surgery in general or regional anesthesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Respondents underwent elective, semi-elective or acute surgery under general or regional anaesthesia (orthopaedics and traumatology, general and vascular surgery, neurosurgery, gynaecology, otorhinolaryngology, urology, eye surgery). Preoperative and postoperative testing took place in the anaesthesiology outpatient clinic or at hospital ward.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Postoperative Cognitive Dysfunction as Geriatric Syndrome | Patients above 65 years old undergoing surgery in general or regional anesthesia. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Results of MMSE before operation, descriptive statistics. | Posted | Count of Participants | Participants | 2 days before operation |
|
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Adverse events were not monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Postoperative Cognitive Dysfunction. | Patients above 65 years old undergoing surgery in general or regional anesthesia. Patients with adverse events were excluded from the study. Origin of adverse events were not associated with the testing of cognitive function (study was observational). Adverse events were: positive test (PCR or antigen) for SARS-CoV-2, severe pain after operation (defined in Numeric Rating Scale as greater than 7), acute respiratory failure, development of somnolence, septic shock after operation or death. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Klára Nekvindová | Thomas Bata Hospital, Zlin, Czech Republic | +420 577 552 280 | klara.nekvindova@bnzlin.cz |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2024 | Sep 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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. | 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. | 3rd day after operation |
| 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 | 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) | 2 days before operation |
| Social Anamnesis - Stairs or Elevator | Respondents living at home with stairs and respondents living at home with an elevator | 2nd day before operation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Respondents underwent elective, semi-elective or acute surgery under general or regional anaesthesia (orthopaedics and traumatology, general and vascular surgery, neurosurgery, gynaecology, otorhinolaryngology, urology, eye surgery). Preoperative and postoperative testing took place in the anaesthesiology outpatient clinic or at hospital ward. | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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| Primary | 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. | Posted | Count of Participants | Participants | 3rd day after operation |
|
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| Primary | 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. | Patients above 65 years old undergoing surgery in general or regional anesthesia. | Posted | Count of Participants | Participants | 2 days before operation |
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| Primary | 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. | Posted | Count of Participants | Participants | 3rd day after operation |
|
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| Primary | 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. | Patients above 65 years old undergoing surgery in general or regional anesthesia. | Posted | Count of Participants | Participants | 2 days before operation |
|
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| Primary | 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. | Posted | Count of Participants | Participants | 3rd day after operation |
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| Secondary | 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 | Posted | Count of Participants | Participants | 2 days before operation |
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| Secondary | Social Anamnesis Before Operation- Type of Accommodation | Type of accommodation was assessed before operation, options were: house, apartment or institutional accommodation | Posted | Count of Participants | Participants | 2 days before operation |
|
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| Secondary | 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) | Posted | Count of Participants | Participants | 2 days before operation |
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| Secondary | Social Anamnesis - Stairs or Elevator | Respondents living at home with stairs and respondents living at home with an elevator | Posted | Count of Participants | Participants | 2nd day before operation |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Title | Measurements |
|---|---|
|
| severe cognitive impairment |
|
| Wilcoxon (Mann-Whitney) |
| 0.023 |
| Other |
Mann-Whitney U test before operation. |
| Title | Measurements |
|---|---|
|
| 4 = living with very mild frailty |
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| 5 = living with mild frailty |
|
| 6= living with moderate frailty |
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| 7= living with severe frailty |
|
| 8= living with very severe frailty |
|
| 9= terminally ill |
|
| Spearman's rank correlation coefficient |
| <0.0001 |
| Other |
Spearman's rank correlation coefficient was used. |
| Correlation of Clinical frailty scale with Clock drawing test before operation. | Spearman's rank correlation coefficient | <0.0001 | Other | Spearman's rank correlation coefficient was used. |