Postoperative Cognitive Dysfunction as Geriatric Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction

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.

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• Czechia
  • Zlín, Czechia, 76001
    • ThomasBH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients 65 years old and older undergoing surgical procedure in general or regional anesthesia or analgosedation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Group 1; Patients above 65 years old undergoing surgery in general or regional anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tomas Bata Hospital, Czech Republic

Publications and helpful links

Helpful Links

• outcomes of pilot study - 2021

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: December 10, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: surgery; POCD; PND; anesthesia, elderly people
• Additional Relevant MeSH Terms: Mental Disorders; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Postoperative Cognitive Complications; Cognitive Dysfunction
• Other Study ID Numbers: ThomasBH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No