Postoperative Cognitive Dysfunction as Geriatric Syndrome

NCT05648890 | Completed Results

• 1 other identifier: ThomasBH
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Keywords

anesthesia, elderly people; PND; POCD; surgery

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Clinical Frailty Scale Before Operation

  2 days before operation

• Social Anamnesis Before Operation- Type of Accommodation

  2 days before operation

• Social Anamnesis During Preanesthesia Exam - Living Situation

  2 days before operation

• Social Anamnesis - Stairs or Elevator

  2nd day before operation

Study Arms (1)

Group 1

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age 65 or older
• absence of sensory impairment (deafness)
• full legal capacity
• informed consent
• ability to speak
• elective or acute surgical procedure

You may not qualify if:

• somnolence, coma
• sepsis
• Glasgow coma scale 14 and less
• known psychiatric disease
• effect of premedication, drugs

Sponsors & Collaborators

• Tomas Bata Hospital, Czech Republic: lead

Study Sites (1)

ThomasBH

Zlín, 76001, Czechia

Location

Related Links

• outcomes of pilot study - 2021

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Klára Nekvindová
• Organization: Thomas Bata Hospital, Zlin, Czech Republic

klara.nekvindova@bnzlin.cz

+420 577 552 280

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MUDr. Klára Nekvindová - Principal Investigator

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 13, 2022
• Study Start: October 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: November 22, 2023
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Locations

CZ (1)