Trial Outcomes & Findings for Postoperative Cognitive Dysfunction as Geriatric Syndrome (NCT NCT05648890)

NCT ID: NCT05648890

Last Updated: 2025-02-26

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 203 participants
• Primary outcome timeframe: 2 days before operation
• Results posted on: 2025-02-26

Participant Flow

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.

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.

Participant milestones

Measure	Postoperative Cognitive Dysfunction Patients above 65 years old undergoing surgery in general or regional anesthesia.
Overall Study STARTED	203
Overall Study COMPLETED	164
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postoperative Cognitive Dysfunction as Geriatric Syndrome

Baseline characteristics by cohort

Measure	Group 1 - Postoperative Cognitive Dysfunction as Geriatric Syndrome n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Age, Continuous	72 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	164 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Czechia	164 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days before operation

Population: Results of MMSE before operation, descriptive statistics.

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.

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Postoperative Cognitive Dysfunction - Results of MMSE Before Operation normal cognitive capacity before operation	79 Participants
Postoperative Cognitive Dysfunction - Results of MMSE Before Operation light cognitive impairment before operation	43 Participants
Postoperative Cognitive Dysfunction - Results of MMSE Before Operation modern impairment before operation	37 Participants
Postoperative Cognitive Dysfunction - Results of MMSE Before Operation severe cognitive impairment before operation	5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Postoperative Cognitive Dysfunction - Results of MMSE After Operation normal cognitive capacity	77 Participants
Postoperative Cognitive Dysfunction - Results of MMSE After Operation light cognitive impairment	43 Participants
Postoperative Cognitive Dysfunction - Results of MMSE After Operation modern impairment	38 Participants
Postoperative Cognitive Dysfunction - Results of MMSE After Operation severe cognitive impairment	6 Participants

PRIMARY outcome

Timeframe: 2 days before operation

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

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.

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Postoperative Cognitive Dysfunction - TEGEST Test Before Operation normal cognition	40 Participants
Postoperative Cognitive Dysfunction - TEGEST Test Before Operation impairment	124 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Postoperative Cognitive Dysfunction - TEGEST Test After Operation normal cognition	77 Participants
Postoperative Cognitive Dysfunction - TEGEST Test After Operation cognitive impairment	87 Participants

PRIMARY outcome

Timeframe: 2 days before operation

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

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.

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation normal cognition	21 Participants
Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation impairment	143 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation normal cognition	21 Participants
Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation impairment in cognition	143 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Clinical Frailty Scale Before Operation 1= very fit	9 Participants
Clinical Frailty Scale Before Operation 2 = fit	43 Participants
Clinical Frailty Scale Before Operation 3 = managing well	24 Participants
Clinical Frailty Scale Before Operation 4 = living with very mild frailty	23 Participants
Clinical Frailty Scale Before Operation 5 = living with mild frailty	24 Participants
Clinical Frailty Scale Before Operation 6= living with moderate frailty	22 Participants
Clinical Frailty Scale Before Operation 7= living with severe frailty	14 Participants
Clinical Frailty Scale Before Operation 8= living with very severe frailty	5 Participants
Clinical Frailty Scale Before Operation 9= terminally ill	0 Participants

SECONDARY outcome

Timeframe: 2 days before operation

Type of accommodation was assessed before operation, options were: house, apartment or institutional accommodation

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Social Anamnesis Before Operation- Type of Accommodation apartment	100 Participants
Social Anamnesis Before Operation- Type of Accommodation house	40 Participants
Social Anamnesis Before Operation- Type of Accommodation institution	24 Participants

SECONDARY outcome

Timeframe: 2 days before operation

Living situation of the patients was assessed before operation. Options were living alone or living with someone (family member)

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Social Anamnesis During Preanesthesia Exam - Living Situation living with family	118 Participants
Social Anamnesis During Preanesthesia Exam - Living Situation lviing alone	46 Participants

SECONDARY outcome

Timeframe: 2nd day before operation

Respondents living at home with stairs and respondents living at home with an elevator

Outcome measures

Measure	Results of MMSE n=164 Participants Patients above 65 years old undergoing surgery in general or regional anesthesia.
Social Anamnesis - Stairs or Elevator stairs	53 Participants
Social Anamnesis - Stairs or Elevator elevator	111 Participants

Adverse Events

Postoperative Cognitive Dysfunction.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Klára Nekvindová

Thomas Bata Hospital, Zlin, Czech Republic

Phone: +420 577 552 280

Email: klara.nekvindova@bnzlin.cz

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place