Cognitive Dysfunction
Conditions
Keywords
anesthesia, elderly people, PND, POCD, surgery
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.
Interventions
None listed
Sponsors
Tomas Bata Hospital, Czech Republic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation | 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. |
| Postoperative Cognitive Dysfunction - Results of MMSE After Operation | 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 | 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 | 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 | 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 - Results of MMSE Before Operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Anamnesis Before Operation- Type of Accommodation | 2 days before operation | Type of accommodation was assessed before operation, options were: house, apartment or institutional accommodation |
| Social Anamnesis During Preanesthesia Exam - Living Situation | 2 days before operation | Living situation of the patients was assessed before operation. Options were living alone or living with someone (family member) |
| Social Anamnesis - Stairs or Elevator | 2nd day before operation | Respondents living at home with stairs and respondents living at home with an elevator |
| Clinical Frailty Scale Before Operation | 2 days 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 |
Countries
Czechia
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Postoperative Cognitive Dysfunction as Geriatric Syndrome Patients above 65 years old undergoing surgery in general or regional anesthesia. | 164 |
| Total | 164 |
Baseline characteristics
| Characteristic | Group 1 - Postoperative Cognitive Dysfunction as Geriatric Syndrome |
|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 164 Participants |
| Region of Enrollment Czechia | 164 Participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 3rd day after operation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation | normal cognition | 21 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation | impairment in cognition | 143 Participants |
Comparison: Correlation between Clock drawing test and MMSE after operation.p-value: <0.0001Spearman's rank correlation coefficient
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.
Time frame: 2 days before operation
Population: Patients above 65 years old undergoing surgery in general or regional anesthesia.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation | normal cognition | 21 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation | impairment | 143 Participants |
Comparison: Correlation between MMSE and Clock drawing test before operation.p-value: <0.001Spearman's rank correlation coefficien
Comparison: Clock drawing before operation.p-value: 0.023Wilcoxon (Mann-Whitney)
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.
Time frame: 3rd day after operation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE After Operation | light cognitive impairment | 43 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE After Operation | modern impairment | 38 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE After Operation | normal cognitive capacity | 77 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE After Operation | severe cognitive impairment | 6 Participants |
Comparison: Correlation between MMSE and TEGEST after operationp-value: <0.001Spearman's ran correlation coefficient
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.
Time frame: 2 days before operation
Population: Results of MMSE before operation, descriptive statistics.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE Before Operation | normal cognitive capacity before operation | 79 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE Before Operation | light cognitive impairment before operation | 43 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE Before Operation | modern impairment before operation | 37 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - Results of MMSE Before Operation | severe cognitive impairment before operation | 5 Participants |
Comparison: Correlation between MMSE and TEGEST test before operation.p-value: <0.0001Spearman's rank correlation coefficient
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.
Time frame: 3rd day after operation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Postoperative Cognitive Dysfunction - TEGEST Test After Operation | cognitive impairment | 87 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - TEGEST Test After Operation | normal cognition | 77 Participants |
Comparison: Correlation between TEGEST and clock drawing test after operation.p-value: <0.001Spearman's rank correlation coefficient
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.
Time frame: 2 days before operation
Population: Patients above 65 years old undergoing surgery in general or regional anesthesia.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Postoperative Cognitive Dysfunction - TEGEST Test Before Operation | normal cognition | 40 Participants |
| Results of MMSE | Postoperative Cognitive Dysfunction - TEGEST Test Before Operation | impairment | 124 Participants |
Comparison: Correlation between TEGEST and Clock drawing test before operation.p-value: <0.0001Spearman's rank correlation coefficient
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
Time frame: 2 days before operation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Clinical Frailty Scale Before Operation | 3 = managing well | 24 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 4 = living with very mild frailty | 23 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 5 = living with mild frailty | 24 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 6= living with moderate frailty | 22 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 7= living with severe frailty | 14 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 8= living with very severe frailty | 5 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 9= terminally ill | 0 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 1= very fit | 9 Participants |
| Results of MMSE | Clinical Frailty Scale Before Operation | 2 = fit | 43 Participants |
Comparison: Correlation of Clinical frailty scale with MMSE before operation.p-value: <0.0001Spearman's rank correlation coefficient
Comparison: Correlation of Clinical frailty scale with TEGEST before operation.p-value: <0.0001Spearman's rank correlation coefficient
Comparison: Correlation of Clinical frailty scale with Clock drawing test before operation.p-value: <0.0001Spearman's rank correlation coefficient
Secondary
Social Anamnesis Before Operation- Type of Accommodation
Type of accommodation was assessed before operation, options were: house, apartment or institutional accommodation
Time frame: 2 days before operation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Social Anamnesis Before Operation- Type of Accommodation | apartment | 100 Participants |
| Results of MMSE | Social Anamnesis Before Operation- Type of Accommodation | house | 40 Participants |
| Results of MMSE | Social Anamnesis Before Operation- Type of Accommodation | institution | 24 Participants |
Comparison: Respondents living at a house or in apartment and relationships with Clinical frailty scale.p-value: 0.562Wilcoxon (Mann-Whitney)
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)
Time frame: 2 days before operation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Social Anamnesis During Preanesthesia Exam - Living Situation | lviing alone | 46 Participants |
| Results of MMSE | Social Anamnesis During Preanesthesia Exam - Living Situation | living with family | 118 Participants |
Comparison: Respondents living with with family or alone and relationship with Clinical frailty scale.p-value: 0.129Wilcoxon (Mann-Whitney)
Secondary
Social Anamnesis - Stairs or Elevator
Respondents living at home with stairs and respondents living at home with an elevator
Time frame: 2nd day before operation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Results of MMSE | Social Anamnesis - Stairs or Elevator | stairs | 53 Participants |
| Results of MMSE | Social Anamnesis - Stairs or Elevator | elevator | 111 Participants |
Comparison: Relationship between respondents living at home with stairs and respondents living at home with an elevator and Clinical frailty scale.p-value: 0.019Wilcoxon (Mann-Whitney)